Law - Exam ii - 2
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In Nebraska, liquid controlled substances in opened containers which originally contained ____________________ or less or compounded liquid controlled substances within the facility where they were compounded may be destroyed if witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the facility and recorded.
In Nebraska, liquid controlled substances in opened containers which originally contained fifty milliliters or less or compounded liquid controlled substances within __________________________________ may be destroyed if witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the facility and recorded.
The facility where they were compounded
In Nebraska, liquid controlled substances in opened containers which originally contained fifty milliliters or less or compounded liquid controlled substances within the facility where they were compounded may be destroyed if_______________________________________________________________________________.
Witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the facility and recorded
In Nebraska, Solid controlled substances in opened unit-dose containers or which have been adulterated within a hospital where they were to be administered to patients in such hospital may be destroyed if
Witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the hospital and recorded
In Nebraska, If the owner is a resident of a long-term care facility or hospital, a controlled substance listed in Schedule II, III, IV, or V shall be destroyed by__________________________________________________________________________________
two individuals credentialed under the Uniform Credentialing Act and designated by the facility or hospital
As mentioned in the above statute, ________ methods are available in Nebraska for the destruction of controlled substances that are part of a registrant's inventory.
Is a DEA Form 41 used to document the wasting of controlled substances?
No, However, appropriate internal records must be maintained of any such wasting.
What is wasting of a controlled substance?
- liquid controlled substances in opened containers which originally contained fifty milliliters or less or compounded liquid controlled substances within the facility where they were compounded
- solid controlled substances in opened unit-dose containers or which have been adulterated (e.g., dropped on the floor) within a hospital where they were to be administered to patients at such hospital
- being destroyed
If a partial ampoule of a controlled substance is used in a surgical procedure, the remaining liquid in the ampoule must be wasted_________________________________.
and witnessed by two credentialed individuals
If a partial ampoule of a controlled substance is used in compounding a product in a Nebraska pharmacy, the remaining liquid in the ampoule must be wasted and_________________________________.
witnessed by two credentialed individuals
In the past, Nebraska required a ________________________________ to be involved in the various destructions of controlled substances. However, the statute was repealed.
member or members of the healing arts
When a pharmacy plans to discontinue doing business as a pharmacy, it can do what with its controlled substances?
- Transfer to another pharmacy registrant
- Return them to the distributor registrant or a reverse distributor registrant
- Have them destroyed by a pharmacy inspector
The pharmacy discontinuing business must:
- 1. notify the nearest DEA Office at least 14 days in advance of the date on which the planned transfer will occur
- 2. take a complete inventory of all controlled substances on hand on the date of the planned transfer
- 3. Send the Certificate of Registration, any blank (i.e., unused or unexecuted) paper DEA Form 222, and any unused DEA Form 222a or 222d to the DEA, the applicable state department, or a state pharmacy inspector. It is recommended that "VOID" be written on all such forms. On the day that the controlled substances are transferred to another registrant:
When a person discontinues a pharmacy business what must they do to transfer their controlled substances:
1. all Schedule II controlled substances must be transferred pursuant to a paper DEA Form 2222. all Schedule III, IV, or V controlled substances must be transferred pursuant to an invoice
In Nebraska, the licensee must notify the Department in writing _____________ before a pharmacy is sold, leased, discontinued, or moved to a new premises.
In Nebraska, the pharmacist-in-charge (PIC) of a pharmacy that ceases legal existence, discontinues business, or has a change of ownership must notify the Department within __________________ of closing.
In Nebraska, the pharmacist-in-charge (PIC) of a pharmacy that ceases legal existence, discontinues business, or has a change of ownership must notify the Department within 15 days of closing about the
- 1. sale or other disposition of legend drug, device, or biological inventory
- 2. sale or other disposition of controlled substances and controlled substances invoices and inventory records, and
- 3. location of all patient records including prescription files
- 4. PIC must return the pharmacy's license to the Nebraska DHHS and must notify patients of that pharmacy that they will need to seek service elsewhere. That notification can be accomplished through: advertisement in a newspaper appropriate to the location of the pharmacy, written notice to patients of the pharmacy, or other such notice as is appropriate
A pharmacy registrant shall notify the DEA Field Division Office in the area, in writing, of the theft or significant loss of any controlled substances within ___________________ of discovery of such loss or theft.
one business day
When details concerning a theft or loss are unknown at the time of discovery, DEA recommends initial notice be provided by ______________________________ of the theft or significant loss.
Faxing a short statement to DEA advising
What form should a pharmacy registrant complete, and submit to the DEA Field Division Office in the area after a theft or loss?
DEA Form 106
What does the DEA define as a significant loss?
Does any theft have to be reported?
Yes, for a controlled substance
Is the breakage or spillage of controlled substances considered a loss?
No, but is a disposal matter and must be reported on DEA Form 41.
According to the DEA, when determining whether a loss is significant, a registrant should consider the following factors:
- 1. Quantity lost in relation to the type of business
- 2. The specific controlled substances lost
- 3. Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
- 4. A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
- 5. Whether the specific controlled substances are likely candidates for diversion;
- 6. Local trends and other indicators of the diversion potential of the missing controlled substance.
The DEA Form 106 must include the following information:
- 1. Name and address of the firm (e.g., pharmacy),
- 2. DEA registration number,
- 3. Date of theft or loss (or when discovered if not known) ,
- 4. Name and telephone number of local police department (if notified) ,
- 5. Type of theft (e.g., night break-in, armed robbery),
- 6. The serial numbers of any paper DEA Form 222 that were stolen,
- 7. List of identifying marks, symbols, or price codes (if any) used by the pharmacy on the labels of the containers, and
- 8. A listing of controlled substances missing, including the strength, dosage form, and size of container (in milliliters if liquid form) or corresponding National Drug Code numbers.
(T/F) A registrant should primarily rely on computer records to determine the quantity stolen or lost, as those records may be most accurate.
False, those records may not be accurate
Is it required by federal law that a perpetual record-keeping system in place for all Schedule II controlled substances?
No, but it may be wise, even for some Schedule III’s as well
The ______________________________ the DEA Form 106 must be sent to the nearest DEA Office. The registrant must keep a copy for its records.
original and duplicate copy of
A copy of the DEA Form 106 must be sent to the ________________________________________.
Nebraska Department of Health and Human Services, Division of Public Health
While not required by law, in the event of a loss or theft, it is recommended that a copy of DEA form 106 be sent to the_____________________________________________________________.
Diversion Captain at the Nebraska State Patrol Headquarters, to the Division of Investigation of the Nebraska Department of Health and Human Services, and to the respective Nebraska pharmacy inspector
What is Cold storage?
- Any temperature not > 8C (46F)
- Refrigerator 2 to 8C (36 to 46F)
- Freezer -25 to -10C (-13 to 14F)
What is Cool storage?
8 to 15C (46 to 59F). Alternatively may be stored in a refrigerator, unless otherwise specified. Do not store in a warmer place.
What is Room temperature?
The temperature prevailing in a working area.
What is Controlled room temperature?
20 to 25C (68 to 77F)
What is Warm?
30 to 40C (86 to 104F)
What is Excessive heat?
What Container Requirements:
Clean and must not interact physically or chemically with the article placed in it so as to alter the strength, quality, or purity of the article beyond the official requirements.
A well-closed container protects the contents from:
Extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution.
A tight container protects the contents from:
- Contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution
- And is capable of tight reclosure
(T/F)A pharmacist must be aware of special storage and handling requirements for all drug products.
When dispensing sublingual nitroglycerin tablets - remind the patient ot:
"to prevent loss of potency, keep these tablets in the original container" and to "close tightly immediately after each use"
When dispensing dabigatran etexilate mesylate (Pradaxa) capsules must only be dispensed and stored in:
- Original bottles or blister packages because of the potential for product breakdown from moisture and subsequent loss of potency
- Must not be placed in pill boxes or pill organizers.
(T/F) If tablets or capsules are dispensed in the original container, some patients should be counseled not to take the foreign looking object (i.e., desiccant) that may also be in the container along with the tablets or capsules.
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