Pharmacy Operations Flashcards

(74 cards)

1
Q

How long to keep all prescription records? (Includes transfers in/out)

A

5 years minimum

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2
Q

How long to keep OTC PSE purchase records?

A

4 years minimum

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3
Q

How long to keep any use of DEA 222 Forms? (includes copes)

A

2 years minimum

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4
Q

How long to keep patient records (profiles) & drug orders? (invoices/inventory)

A

5 years minimum

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5
Q

How long to keep CS inventory records?

A

5 years

The PIC is responsible for signing & dating CS inventory documentation

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6
Q

How should C2 Inventory records be kept?

A

Must be kept separate from all other records

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7
Q

How should prescription files be kept?

A

In three (3) separate files

CII vs CIII, CIV, CV vs Non-CS

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8
Q

How should electronic prescription files be put into the computer system?

A

Accurately - the pharmacist must sign the log

Attesting that all RX information entered into the computer has been reviewed & is accurate

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9
Q

All pharmacies must have effective controls against the diversion of drugs in place but specifically through…

A
  • Written and established policies
  • Electronically Alarm
  • Video System
  • Any security breaches must be reported to the Board / IL Department
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10
Q

What must the Patient Profile contain?

A
  • Patient Name & Address
  • Patient Phone #
  • Date of Birth
  • Gender
  • Relative Comments (about therapy)
  • Allergies
  • Drug Reactions
  • Idiosyncrasies
  • Disease States
  • Etc.
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11
Q

A pharmacy can sell legend drugs to another pharmacy as long as…

A

The sales do not account for more than 5% of the pharmacy’s total sales of Rx drugs

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12
Q

Where must expired / misbranded / adulterated drugs be located in the pharmacy?

A

Quarantined and separated from the other drugs

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13
Q

What are “Automated Pharmacy Systems” also known as?

A

Automated Dispensing and Storage Systems

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14
Q

Define “Automated Pharmacy Systems”

A

CAN serve as Emergency Kits or After-Hours Cabinets (but do not have to)
* Sometimes they’re just a place to store drugs at a location without a pharmacy
* To be dispensed later after RX approval by a pharmacist

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15
Q

When can “Automated Pharmacy Systems” be used?

A

Only in setting that ensure medication orders and prescriptions (THAT ARE REVIEWED BY A PHARMACIST)

Also in accordance with established policies and procedures

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16
Q

Are there any security and/or privacy requirements needed in place?

A

Must be secured to prevent unauthorized access

Must maintain patient confidentiality

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17
Q

How should medications be maintained?

A

Unit-of-use packaging (for single patient use)

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18
Q

For “Automated Pharmacy Systems”

Who’s in charge of documentation? What is required to be documented?

A

The Pharmacy

Quality Assurance Docs; and
Detailed Transaction Records
* Identification of the person (stocking/restocking)
* Pharmacist checking for the accuracy of the medications (to be stocked/restocked)

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19
Q

Who may access “Automated Pharmacy Systems” for the purpose of stocking/restocking medications?

A

Only by Interns / Technicians that are designated & trained by the PIC

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20
Q

For “Automated Pharmacy Systems”

What must happen before the medication can be released?

A

Pharmacist (at the home pharmacy) must approve the release
* The RX (written or electronic) must be obtained & verified by the pharmacist
* Kept for 5 years; like all other Rx records

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21
Q

Explain Hospital: Absence of Pharmacist

A

“After-Hours Cabinet” may be used (by Specifically Authorized Personnel)

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22
Q

What documentation is required for “After-Hours Cabinet(s)” in a Hospital when there is an absence of a pharmacy?

A

Physician’s Orders; authorizes the removal of the drug

Log Documentation
* Date & Time
* Drug
* Amount, etc.

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23
Q

When is an authorized nurse to enter the pharmacy to retrieve a medication? What is required?

A

Pharmacist is absent

Drug needed is not in the after-hours cabinet

Must leave copy of the Physician’s Order (in the container) with the nurses signature

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24
Q

What are Emergency Kits? Explain what they can be used for.

A

Usually prepared by a nearby pharmacy

Drugs contained, belong to the pharmacy (included in inventory count)

May be used for Immediate Need of Patients in an LTCF

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25
Who is responsible for oversight of the Emergency Kit?
The consultant pharmacist
26
Does the Consultant Pharmacist have any further responsibilities or tasks for Emergency Kits?
Monthly checks (of the drugs inside)
27
When can Emergency Kits be opened? Who is allowed access? When are drugs allowed to be removed from the kit?
Only accessible pursuant to a physician's order Only accessible by authorized personnel (e.g., nursing staff) Only in emergencies
28
How must Emergency Kits be sealed once opened?
Sealed in a way that indicates it has been opened * Electronic code * Tamper-resistant packaging
29
Who should be notified when an Emergency Kit has been opened? When?
The consultant pharmacist within 24 hours of the kit being opened
30
What must the label on the outside of the Emergency Kit contain?
BUD; The earliest expiration date of any drug inside
31
What must always be done after the Emergency Kit has been used?
Notify the consultant pharmacist within 24 hours of being opened Returned to pharmacy to be checked & restocked "Proof of Use Sheet"
32
How long should pharmacies keep "Proof of Use Sheet" copies from Emergency Kits?
2 years minimum
33
What may Emergency Kits contain inside? Are there limitations?
May contain both CS and Non-CS * Should be unit-dose or single use packages No more than 10 CS No more than 3 single injectables of each CS
34
Who has property over the drugs kept in Emergency Kits located in facilities? What does this mean?
The pharmacy that provided the Emergency Kit * Drugs must be included in the Inventory Counts
35
When is CS Inventory required in IL
Annually
36
Which CS drugs have to be exactly counted?
C2 Drugs CIII, CIV, CVs that have > 1,000 tablets/capsules in bottle
37
When should the annual CS inventory be done?
Must be either before or after the business day * Not during business hours
38
Other than the annual CS inventory, what other events also require CS inventory to be taken?
PIC leaving/replaced Ideally the incoming/outgoing PICs together
39
When should theft of ANY medication be reported? To whom?
Reported to the Board / IL Department within 1 day
40
When should theft of CS medication be reported? To whom? Any further requirements?
Complete DEA Form 106 within 1 day (of discovery of theft) A copy must be sent tot he Division within 1 day of submission to the DEA * With pharmacists' name & signature
41
What is required of the pharmacy when CS medications have been delivered?
Requires the pharmacist to review the invoice/medication(s) have been delivered and ensure that it is Accurate & complete Must have Signature & Date
42
When should pharmacies not accept drugs being delivered to the pharmacy?
When drugs have been adulterated or not properly branded Example - stored (in in a way by the manufacturer/wholesaler) that was outside the acceptable temperature ranges
43
When can a pharmacy select an interchangeable biologic product?
FDA says it is equivalent Prescriber did not indicate substitution is not allowed = DAW
44
Who should be notified when substituting a medication for a generic or interchangeable biologic product?
Pharmacist must inform the patient of the substitution Pharmacist must inform the prescriber (5 days since dispensing)
45
Explain the FDA Purple Book
Shows the list of licensed biologics for interchangeability
46
When are pharmacies NOT allowed to substitute therapeutically equivalent drugs (generics)?
Prescriber indicates substitution is not allowed (DAW) Patient specifically requests brand to be dispensed
47
What type of compounding is okay for practitioner "office-use" in small amount?
Non-Sterile Compounding Label must say "Not for Re-Sale"
48
Explain "Compounding Self-Inspection Reports"
A separate self-inspection form with one (1) for Sterile Compounding and one (1) for Non-Sterile Compounding Must be filled out in addition to the general self-inspection
49
Which type of compounding requires a 24 hour phone # be included on the prescription label
Sterile Compounding
50
When is a separate license required for pharmacies
Different Address Location & Pharmacy Activity
51
Where must pharmacy licenses be kept within pharmacies?
License(s) must be Clearly Posted in the pharmacy
52
Explain the bound log book that every pharmacy must maintain
Each individual pharmacist involved in dispensing shall sign a statement every day Attests to the fact that the refill information entered has been Reviewed (by him/her) & is Correct as shown
53
What are the physical equipment requirements of a pharmacy?
* Scale * Fridge for drugs (no food/drinks) * Sink with hot & cold water * Proper ventilation * Well lit * Current "library" reference materials (must be kept onsite or readily available electronically)
54
What must be one before any pharmacy remodeling?
Requires notifying IL Department & Obtaining Approval
55
If a pharmacy has a temporary closure of more than 72 hours...
Must notify the IL Department within 72 hours of closure
56
When should the Department be notified of a Reduction of Pharmacy Hours?
Within 30 days
57
Drug storage areas must be contiguous, which means...
Rooms are connected (connecting doors are okay)
58
What is needed in order to maintain and dispense CS medications?
Pharmacy must be registered with the DEA * May be revoked if the registrant is convicted of drug-related offense
59
A new pharmacy application is required if...% of the pharmacy is...
> 50% of the pharmacy is sold; or Transfer of Ownership
60
When a pharmacy closes permanently, who should be notified? When?
Must notify the IL Department Within 30 days of advance before closing
61
What is required when a pharmacy chooses to close permanently? Must return...
Pharmacy License; and CS Registration
62
What is required when a pharmacy chooses to close permanently? Final CS Inventory
Give copy of CS Inventory to the IL Department within 30 days
63
What is required when a pharmacy chooses to close permanently? IL Department: Copy of All RX Files
Within 30 days (before closing)
64
What is required when a pharmacy chooses to close permanently? Customers & Rx Recrods
Must notify all customers where Rx Records will be kept At least 15 days in advance (before closing)
65
What is required when a pharmacy chooses to close permanently? Department notified of...
Disposition of Pharmacy Records & Prescription Drugs Copy of Drug Disposal Records
66
Explain Central Fill: Agreement
Outlines which pharmacy is responsible for the offer to counsel Must either have Shared Ownership or Contract in place * Outlines the responsibilities
67
What can Central Fill pharmacies do?
Can do CS and Non-CS medications * For Initial and/or Refill RXs
68
What must Central Fill pharmacies identify during the filling process?
Identify who is responsible during each step of the filling process
69
What must Central Pharmacies share with the home pharmacy?
Patient Profiles
70
Central Fill pharmacies must ensure...
Adequate security measures to protect patient information
71
What are Pharmacy Personnel Termination Reports? When should they be sent to the IL Department?
Required to be completed when termination of pharmacist / technician fired due to action(s) that may have Threatened Patient Safety
72
If a pharmacy licensee (owner) is convicted of a felony related to CS or if provided information on an application?
Pharmacy license may be suspended / revoked
73
When can pharmacists refuse entry for inspections?
All aspects are subject to inspection * Pharmacists / Staff cannot refuse to allow entry
74
Which aspects of the pharmacy are subject to inspection?
May include: * Copying / Verifying records, conducting inventory of CS (basically anything) Any discrepancies must be corrected and/or addressed with the Board / Department