Lecture 21 - Indiana Administrative Code 2 Flashcards

1
Q

What is a cabinet?

A

A mechanical storage device for dispensing drugs

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2
Q

What is a consultant pharmacist?

A

A pharmacist who practices pharmacy at a LTCF or other residence other than as a supplying pharmacist

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3
Q

What is a consulting?

A

Provision of nonsupply related cognitive services

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4
Q

What are emergency drugs?

A

Drugs that are required to meet intermediate patient needs, and are not available from another source in sufficient time to prevent risk of harm to patients

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5
Q

What is a pharmacist in charge?

A

Pharmacist who directs the activities of the institutional pharmacy

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6
Q

What are quality-related event?

A

Inappropriate provision of pharmaceutical services which may result in an adverse health incident

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7
Q

What is a reversible condition?

A

Condition that requires intervention to resolve in a reasonable time

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8
Q

What is a sentinel event?

A

Unexpected occurrence involving a serious adverse effect

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9
Q

What is a temporary condition?

A

Condition that resolves un a reasonable time without intervention

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10
Q

What must a pharmacist in charge do?

A

-Establish and carry out performance improvement program
-Develop policies and procedures manual of sufficient scope and detail to allow safe and effective pharmacy practice
-Develop policies and procedures that specify duties to be performed by pharmacy technicians

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11
Q

What requirements must be met for drugs in a cabinet?

A

-All drugs in the cabinet must be properly labeled and repackaged, in amounts sufficient for a maximum of 24 hours of use
-When drugs are used from the cabinet, they must be tied to a physician’s order or accountability record
-Drugs in cabinets must be reviewed by a pharmacist upon return to duty, not more than 24 hours later
-Policies and procedures must be established to implement this section

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12
Q

What can a nurse do when there is no pharmacist available and the drug they need is not in the cabinet?

A

One supervisory licensed nurse in any shift may have access to the pharmacy and may remove drugs, but must record on a suitable form:
-Name and strength of the drug
-Amount
-Date and time
-Signature of the nurse
-A copy of the order

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13
Q

What must pharmacy policy and procedure assure for any emergency drugs?

A

-Availability, Control and Security of emergency drug carts, kits, or boxes in the pharmacy and patient care areas
-Determination of drugs and quantities of drugs to be included
-Labeling for expiration date
-Process for restocking
-Security measures to prevent unauthorized access

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14
Q

What must drug kits be labeled with?

A

-Drug name
-Drug strength or size
-Quantity included
-Expiration date of the kit (earliest expiration of any of the drugs in the kit)

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15
Q

What must drugs in a drug kit for an LTCF be labeled with?

A

-Drug name
-Drug strength or size, if applicable
-Name of the manufacturer, packer, or distributor
-Lot number
-Expiration date

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16
Q

What must a nurse document when removing drugs from an emergency kit?

A

-Name of the patient
-Name of the drug
-Strength of the drug
-Quantity removed
-Date and time of removal

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17
Q

How long should records of processes, analysis, and consecutive measures related to quality related events be kept?

A

Records must be maintained for at least 2 years

18
Q

What must be required in documentation of quality related events?

A

-Each quality related or sentinel event is documented by the pharmacist to whom it is first described on the same day as it is described
-A description of the event sufficient to permit analysis
-Pharmacist in charge shall summarize efforts to improve processes
-No patient or employee names shall names shall be included in the reporting
-A member of the board may review this documentation to assure compliance

19
Q

What must all drugs besides unit-dose packages be labeled with?

A

-Patient identification
-Drug name
-Strength if applicable
-Route of administration
-Quantity
-Pharmacists initials
-Location of patient within the institution (room number)

20
Q

What must be included on drug labeling of unit-dose packages?

A

-Drug name
-Strength if applicable
-Control number and/or expiration date

21
Q

When may a patient self-administer drugs in an institutional facility?

A

-If specifically authorized by the treating or ordering physician and the patient’s knowledge of self-administration has been evaluated or if the patient has received training in the proper manner of self-administration by a pharmacist according to hospital policy
-There is no risk of harm to the patient

22
Q

What should an institutional pharmacy do with drugs that are brought into the institution by the patient?

A

Institutional pharmacy may not touch drugs that are brought into the institution by the patient

23
Q

When is use of a patient’s own medication permitted in an institutional pharmacy?

A

-The patient can maintain their own medication at the bedside or under control of nursing personnel if special storage requirements apply; and
-The nurses in charge of that patient’s care witness the administration and maintain records of medication use

24
Q

What is a biological safety cabinet?

A

Specialized, enclosed, ventilated workspace suitable for preparation of low to moderate risk agents

25
What is a class 100 environment (ISO class 5)?
Environment containing less than 100 particles 0.5 microns in diameter per cubic foot of air
26
What does cytotoxic mean?
Pharmaceutical capable of killing living human cells
27
What is a sterile pharmaceutical?
A drug which is free from living microbes and chemical or physical contamination
28
What physical requirements are necessary for sterile pharmaceuticals?
-Environmental control capable of at least ISO class 5 in the designated area -A sink with hot and cold running water convenient but outside the buffer area for hand washing purposes -Disposal containers, including for hazardous waste as needed -Biohazard cabinetry if hazardous drugs are prepared -A refrigerator with a thermometer -Infusion devices if appropriate -Documentation of adequate cleaning and sanitizing of the environment -Environmental control capable of at least ISO class 8 conditions in the buffer area
29
What supplies are needed for sterile pharmaceuticals?
-Needles, syringes, and supplies needed for aseptic admixture -Disinfectant cleaning tools and solutions -Antibacterial hand washing agent -Disposable towels or wipes -Filters and filtration equipment, if utilized -A hazardous drug spill kit if hazardous drugs are prepared -Disposable gowns and gloves
30
What reference materials must be in a pharmacy with sterile pharmaceuticals?
-The handbook on injectable drugs -The King's Guide to Parenteral Admixtures -Another board-approved printed or electronic databases -If preparing hazardous drugs, they must have a copy of the OSHA requirements for handling hazardous drugs
31
What must every sterile pharmaceutical product be labeled with?
-Date of preparation -Patient name and bed number if patient is institutionalized -Name of each drug in the preparation, strength, and amount -Expiration date of the preparation (including time if applicable) -Identification of the dispensing pharmacist and personnel responsible for preparing the sterile pharmaceutical -Storage requirements or special warnings as required
32
What extra stuff must be added to a label of a sterile pharmaceutical product when the patient resides at home?
-Prescription number -Prescribers full name -Name address, and telephone number of the pharmacy -Directions for use, including infusion rate and date and time of administration
33
Where must the fax machine be located?
In a nonpublic area of the licensed pharmacy
34
Can C2s be transferred?
Yes
35
Can a pharmacist refuse a transfer?
No unless it goes against the pharmacists professional judgement
36
What prescriptions require a DEA number to be recorded when transferred?
All
37
What satisfies the requirement for offering to counsel?
-Pharmacist counseling the patient -A pharmacist intern/extern counseling, and then making a bona fide offer for the pharmacist to counsel -If the patient is not present and did not authorize another individual to receive information, or if the product is delivered, a written notice containing the pharmacy's phone number and a bona fide offer -Any person in the pharmacy making an offer for the pharmacist to counsel
38
What does NOT satisfy the offer to counsel requirements?
-Making an offer for the patient to ask questions -Shifting the responsibility to the patient for initiating the counseling or selecting the information presented in the counseling -Relaying information through an intermediary, unless related to appropriate communication -Using signs or written notices/information given to the patient
39
How must counseling be done if it can not be done in person?
Over the phone
40
When should the offer to counsel be made?
With each prescription-dispensing visit
41
What security features are present on a prescription?
-Void copy appears once it is photocopied -Indiana security prescription watermark on the back of the Rx blank