Law -Exam II -1
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Schedule __________________controlled substances "shall be stored in a securely locked, substantially constructed cabinet" or "dispersed throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances."
II, III, IV, and V
Schedule II, III, IV, and V controlled substances "shall be ____________________________________" or "______________________________________ to obstruct the theft or diversion of the controlled substances."
- stored in a securely locked, substantially constructed cabinet
- dispersed throughout the stock of noncontrolled substances in such a manner as
Schedule ___ controlled substances "shall be stored in a securely locked, substantially constructed cabinet."
Schedule I controlled substances "shall be stored ________________________________________________."
in a securely locked, substantially constructed cabinet
"stored in a securely locked...cabinet" means that the cabinet must be ________________________ and __________________________. It does not mean that the cabinet _________________________and _______________________.
- opened each time before filling a prescription and locked each time after filling a prescription
- can be opened at the start of business for the day and locked at the end of business for the day.
A "substantially constructed cabinet" does not mean_____________ or _____________.
a metal cabinet or safe
As of____________, federal law required all single and multi-ingredient ephedrine, pseudoephedrine (PSE), and phenylpropanolamine (PPA) products intended for over-the-counter (OTC) sales to be placed behind a counter or in a locked cabinet.
Federal law required all single and multi-ingredient _________________, ________________ and ____________________ products intended for over-the-counter (OTC) sales to be placed behind a counter or in a locked cabinet.
ephedrine, pseudoephedrine (PSE), and phenylpropanolamine (PPA)
____________ products are currently not approved for OTC sales or prescription sales for human use in the United States. However, they may be available as legend drugs for veterinary use in dogs as a treatment for urinary incontinence.
Single-entity and most combination ephedrine products are Schedule __ controlled substances (i.e., legend drugs) in Nebraska and must be stored in_____________________.
- the prescription department
________________________________ and _________________________(but not their generic equivalents) are currently exceptions to ephedrine dropucts scheduling and can be sold as OTC products in Nebraska.
- Primatene tablets and Bronkaid Dual Action Caplets
- (T/F) Primatene tablets and Bronkaid Dual Action Caplets do not need to meet federal requirements for storage in Nebraska.
In Nebraska, the inventory of prescription drug products (i.e., legend drugs) must be stored in._____________________.
a secure location
According to Nebraska law: Loss of prescription inventory or prescription records due to theft or any other cause resulting from failure to secure the inventory or records are _________________________.
grounds for disciplinary action
According to Nebraska law: The prescription inventory and prescription records of the pharmacy must be maintained in a secure location when___________________________.
there is no pharmacist on the premises
According to Nebraska law: Drugs, devices, and biologicals stored in a refrigerator must be kept in_____________________________________.
a separate compartment from food
__________________________________ and _______________________________, allows health care professionals and consumers to voluntarily report to FDA serious problems with the medical products they prescribe, dispense, or use.
FDA's MedWatch program and the FDA Safety and Adverse Event Reporting System
As of 7/1/09, the following statement must be provided to patients with all new and refill prescriptions dispensed by authorized dispensers and pharmacies to consumers:
“Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.” This number is the MedWatch phone number.
The FDA seeks the following types of reports from health care professionals:
- 1. Serious adverse event (fatalities, hospitalizations, and medically significant events) that might be associated with a drug, biologic, medical device, or dietary supplement, especially adverse events not listed in the product labeling.
- 2. Therapeutic failures - drug or device failed to work as it should/ineffective
- 3. Cases of use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.
- 4. Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.
- FDA encourages one to report these problems to MedWatch even if one is not sure____________________________.
- whether or not the product was the cause
The FDA's product recall system has ___________classes of recall.
Class ___ recall being the most serious.
Class ___ recall being the least serious.
Class I recalls are issued when there is a reasonable probability that the product will cause________________, _______________ and ________________.
Serious, adverse health consequences or death
Class II recalls occur when the product________________________________ but___________________________________.
May cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote
Class III recalls apply to products that are___________________________________.
Not likely to cause adverse health consequences
What class of recall is: Coumadin (warfarin sodium) 7.5 mg tablets found to be super potent
What class of recall is acetaminophen elixir found to be contaminated with yeast
What class of recall is methocarbamol 500 mg and 750 mg tablets failed to meet USP specifications for dissolution?
Can a patient return a prescription drug to the pharmacy from which it was dispensed for relabeling and redispensing to another patient?
- Not a good practice unless for disposal purposes
- The FDA has left it up to individual states to develop statutes and/or regulations to regulate such returns.
- Nebraska: Yes if for disposal, in response to a recall, not for salable inventory or re-dispensing, if from a LTC facility and not a controlled substance, approved by the pharmacist, in constant control of the LTC facility, in original unopened contained w/ tamper evident seal and tabs/caps must be in a moisture impermeable container approved by the Board of Pharmacy
Can pharmacies charge a fee for collecting dispensed drugs or devices for disposal or from a long-term care facility for credit or for relabeling and redispensing?
Any person or entity which exercises reasonable care in collecting dispensed drugs or devices for disposal or from a long-term care facility for credit or for relabeling and redispensing pursuant to this section shall be _____________________________________________________________relating to such activities.
immune from civil or criminal liability or professional disciplinary action of any kind for any injury, death, or loss to person or property
Return of ________________________, ___________________________, _________________________ and ________________________from a long-term care facility to the pharmacy is prohibited.
Controlled substances, halved tablets, other broken dosage forms, and extemporaneously compounded tablets and capsules
In Nebraska a unit-dose is defined as a packaging system where the container may not contain doses for a period greater than ____________.
In Nebraska, the pharmacy cannot accept the return of drugs from a long-term care facility after __________________________ time.
(T/F) A drug dispensed according to all of the Nebraska regulatory requirements and accepted for return from a long-term care facility, can be returned to the original stock bottle.
False, it must not be returned to the original stock bottle
(T/F) The calculated expiration date on the label of the initially repackaged drug must be used if it is redispensed to another patent.
True, do not use the original package date of expiration
Under Nebraska law, The Cancer Drug Repository Program Act, a cancer drug can be donated when:
- It is in its original, unopened, sealed, and tamper-evident packaging
- Packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened
- There is no limitation on the number of doses that can be donated
- An injectable cancer drug may be accepted if it does not have temperature requirements other than controlled room temperature.
Any person or entity, including a cancer drug manufacturer, which exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs under the Cancer Drug Repository Program Act or rules and regulations adopted and promulgated under the act shall be immune_______________________________________________ relating to such activities.
from civil or criminal liability or professional disciplinary action of any kind for any injury, death, or loss to person or property
(T/F) Cancer drugs donated under The Cancer Drug Repository Program Act must not be resold.
True, except a participant can charge a reasonable handling fee to redispense it that must not exceed the Medicaid provider dispensing fee that is applicable at the time the dispensing or distribution occurs.
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