CPJE Mine > Chapter 1.1 > Flashcards

Chapter 1.1 Flashcards

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1
Q

T/F: Medicare can only be billed for durable medical equipment (DME) only when the pharmacy has both copies of the original verbal dispensing order(written) and a copy of the completed detailed written order(DWO)

A

True

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2
Q

What qualifies as a durable medical equipment

A

Blood glucose monitors, test strips, lancets and lancet devices
Nebulizers and nebulized drugs
Continuous positive airway pressure (CPAP) machines
Prosthetics, orthotics and supplies
Ostomy supplies
Walkers, scooters, canes and commode seats

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3
Q

To combat counterfeit, misbranded, adulterated and diverted drugs from entering the drug supply, the federal drug supply chain security act(DSCSA) was passed in 2013
True/ false

A

True

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4
Q

The DSCSA act applies to ONLY PRESCRIPTION DRUGS INTENDED FOR HUMAN USE
T/F

A

True

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5
Q
A
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6
Q

The ffg drugs are exempt from the DSCSA ACT

A

OTC DRUGS
vet drugs
Active pharmaceutical ingredients
Blood products for transfusion
Radioactive drugs
Drugs used in imaging studies
Certain iv products
Certain medical gases e.g oxygen
Homeopathic drugs
Compounded preparations

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7
Q

How long must pharmacies capture and maintain TI, TH AND a TS in paper or electronic form for each drug product received from the date of the transaction

A

6

TI- transaction information
TH- transaction history
TS- transaction statement

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8
Q
A
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9
Q

Who must sign for and receive drugs/devices delivered to a pharmacy?

A

A pharmacist

Deliveries to a hospital pharmacy can be made to a central receiving location within the hospital.

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10
Q

What is the time frame for delivering drugs/devices to the licensed pharmacy premises after initial delivery to a hospital(i.e at the central receiving location)?

A

Within one working day

The pharmacist on duty must immediately inventory the drugs or devices upon delivery.this central location is within the hospital

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11
Q

True or false: A pharmacy can take delivery of drugs/devices when it is closed if certain requirements are met.

A

TRUE

Specific requirements must be fulfilled for this to occur.

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12
Q

List the requirements for a pharmacy to take delivery of drugs/devices when closed.

A
  • Drugs/devices placed in a secure storage facility
  • Access limited to the PIC or designated pharmacist
  • Secure storage facility indicates if accessed
  • Written P&Ps for delivery to secure storage
  • Delivery documents left by the agent
  • Pharmacy responsible for drugs/devices and records

These requirements ensure the security and accountability of the drugs/devices delivered.

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13
Q

What types of drugs cannot be purchased, traded, sold, or transferred?

A
  • Adulterated drugs
  • Misbranded drugs
  • Expired drugs

Adulteration involves the quality of the drug, while misbranding involves incorrect or missing label information.

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14
Q

What must be ensured about the drug stock in a pharmacy?

A
  • Clean
  • Orderly
  • Properly stored
  • Properly labeled
  • In-date (not expired)

Maintaining these conditions is essential for safety and compliance.

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15
Q

Define adulteration in the context of drugs.

A
  • Filthy, putrid or decomposed
  • Prepared or stored in unsanitary conditions
  • Contaminated
  • Lack of quality controls or purity testing
  • Strength or purity different from official standards
  • Not recognized in official compendia

Examples include vaccines stored improperly or injectable medications containing contaminants.

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16
Q

What are the key characteristics of misbranding?

A
  • Lack of required information on the package
  • False or misleading information
  • Special precautions not listed
  • Improper packaging
  • Ingredients differ from USP standards

Examples include herbal products claiming to cure diseases or contraceptives lacking required inserts.

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17
Q

True or false: A medication can be both adulterated and misbranded.

A

TRUE

For example, levothyroxine tablets labeled as 100 mcg but actually containing 50 mcg are both adulterated and misbranded.

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18
Q

How often must the hospital drug supply be inspected?

A

At least every 30 days

Inspections include automated dispensing systems, refrigerators, and emergency supply stock.

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19
Q

What should be done with outdated, unusable, recalled, or mislabeled drugs during inspections?

A

They must be removed

Records of inspections must be kept for at least three years.

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20
Q

What must be reported within 24 hours during drug supply inspections?

A

Irregularities

Reports should be made to the PIC and the director or chief executive officer of the healthcare facility.

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21
Q

Fill in the blank: A drug is considered adulterated if it is stored in _______ conditions.

A

unsanitary

This includes any conditions that compromise the drug’s integrity.

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22
Q

What is an example of adulteration?

A

A vaccine stored in the refrigerator instead of the freezer

This can compromise the vaccine’s effectiveness.

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23
Q

What is an example of misbranding?

A

An herbal product claiming to cure cancer

This is misleading and lacks scientific support.

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24
Q

What should be avoided during drug storage to prevent confusion?

A

Storing look-alike, sound-alike drugs close to each other

This helps prevent medication errors.

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25
Where can information regarding **drug and vaccine shortages** be found?
* American Society of Health-System Pharmacists: www.ashp.org/drugshortages * Food and Drug Administration: www.fda.gov/drugs/drugsafety/drugshortages/ * Centers for Disease Control and Prevention: www.cdc.gov/vaccines/vac-gen/shortages/ ## Footnote These websites provide updates on the availability of drugs and vaccines.
26
What are the **proper storage conditions** for drugs?
* Secure manner * Right temperature * Right humidity * Right light ## Footnote Proper storage conditions prevent drugs from becoming adulterated.
27
List the types of drugs that have **additional storage requirements**.
* Controlled Drugs * Investigational New Drugs * Repackaged or Resold Drugs * Recalled Drugs * Expired Drugs * Drug Samples ## Footnote These drugs must be stored separately to avoid misbranding and adulteration.
28
Where should **controlled drugs** be stored?
Locked cabinet or dispersed throughout the other drug stock (on the shelves) ## Footnote Controlled drugs require secure storage to prevent unauthorized access.
29
What is required for **emergency drug supply** at nursing stations?
* Immediately available * Stored in a clearly marked portable container * Sealed by the pharmacist * Contents listed on the outside cover * Includes earliest expiration date of any drugs ## Footnote Emergency supplies must be accessible for medical emergencies.
30
What is a **drug recall**?
A drug is removed from the market because it is defective or potentially harmful ## Footnote Recalls are issued by the FDA or the drug manufacturer and may involve specific batches or lot numbers.
31
True or false: Pharmacies must be positioned to receive notification of **drug recalls**.
TRUE ## Footnote It is essential for pharmacies to be aware of recalls to ensure patient safety.
32
What must pharmacists do if a recall involves specific **batches or lot numbers**?
* Check the stock * Remove the recalled drug from all storage areas ## Footnote This includes patient care areas and automated dispensing cabinets.
33
In a **Class I recall**, who is responsible for notifying the patients?
Patient’s doctor The pharmacist must determine which patients received the drug and notify each patient's prescriber ## Footnote The prescriber must then decide whether to inform the patient.
34
What is the responsibility of the **manufacturer** in a drug recall?
The manufacturer is responsible for notifying its customers, including distributors and patients ## Footnote This ensures that all parties are aware of the recall.
35
What must be done with a recalled drug when it is returned to the pharmacy?
It must be quarantined and labeled appropriately ## Footnote This prevents accidental distribution of the recalled drug.
36
Class II recalls can cause what type of health consequences?
Temporary or reversible adverse health consequences, or the probability of harm is remote ## Footnote Example: recalls of metformin extended-release due to unacceptable levels of NDMA.
37
What is the definition of a **Class III recall**?
Use of or exposure to the drug is not likely to cause adverse health consequences ## Footnote Example: recall of paliperidone extended-release due to failing dissolution tests.
38
What must pharmacies do within **12 hours** of issuing a recall?
Notify the recipient and the board of pharmacy ## Footnote This applies if the recalled compounded preparation can cause serious adverse effects or death.
39
If a recalled drug was dispensed directly to the **patient**, who must be notified?
The patient must be notified ## Footnote This ensures that the individual is aware of the recall and any potential risks.
40
Fill in the blank: A **Class I recall** indicates a reasonable probability that use of the drug will cause serious adverse health consequences or _______.
death ## Footnote Example: fentanyl patches recalled due to packaging errors.
41
What is required for a recall notice for a compounded drug preparation if it was dispensed to a **prescriber**?
The notice must be made to the prescriber, who must ensure the patient is notified ## Footnote This maintains the chain of communication regarding the recall.
42
What is the **timeframe** for notifying the board of pharmacy regarding a recall from an outsourcing facility?
Within 24 hours ## Footnote This is crucial for maintaining safety and compliance.
43
What is the time frame for a pharmacy to report a patient harm event related to **non-sterile compounded products** to the FDA MedWatch program?
Within 72 hours ## Footnote This applies when a pharmacy is made aware that a patient has been harmed by a compounded product prepared by the pharmacy.
44
What is the time frame for reporting harm related to **sterile compounded products** prepared in a hospital satellite pharmacy?
Within 12 hours ## Footnote This is the required reporting time for sterile products prepared in a hospital satellite pharmacy.
45
When must a pharmacy report harm related to **sterile products** prepared by all other pharmacies?
Immediately ## Footnote This includes compounding and non-resident pharmacies.
46
What is the reporting time frame for an **outsourcing facility** aware of patient harm from a compounded product?
Within 15 calendar days ## Footnote This applies when the facility is made aware of the harm caused by their compounded product.
47
What types of drugs can be **donated** to a repository and distribution program in California?
* Drugs in single-use or sealed packages * Unused and not expired drugs * Drugs in unopened, tamper-evident packaging or unit-dose containers * Drugs that have not been adulterated or misbranded * Drugs requiring refrigeration that have been kept refrigerated ## Footnote Controlled substances cannot be donated.
48
What must be established for pharmacies distributing donated drugs to **low-income patients**?
Eligibility requirements ## Footnote Pharmacies can operate a drug repository and distribution program.
49
What must pharmacies do with returned prescription drugs from patients?
Dispose of the returned drug ## Footnote The returned drug cannot be returned to stock or dispensed to another patient.
50
True or false: Pharmacies can return a **wrongly dispensed drug** to stock after it has been returned by a patient.
FALSE ## Footnote The pharmacy must dispose of the returned drug instead.
51
Why is it important to **dispose of drugs properly**?
* Avoid drug abuse * Prevent accidental ingestion * Reduce environmental pollution ## Footnote Proper disposal helps mitigate risks associated with misuse and environmental harm.
52
What regulations has the board adopted regarding drug disposal?
DEA regulations on drug take-back services ## Footnote These regulations outline safe and responsible disposal methods.
53
List the **safe and responsible ways** to dispose of drugs.
* Take-back events * Collection bin/receptacles * Mail-back packages ## Footnote These methods are designed to ensure safe disposal of medications.
54
True or false: Most drugs should be **flushed down the toilet**.
FALSE ## Footnote Most drugs should not be flushed; only a small number of medications are recommended for flushing.
55
What is the **FDA's Flush List**?
A list of drugs that should be disposed of by flushing down the toilet ## Footnote This list includes medications with high potential for misuse or danger.
56
Name three drugs included in the **FDA's Flush List**.
* Buprenorphine * Morphine * Fentanyl-containing products ## Footnote These drugs pose significant risks if not disposed of properly. Others include: Diazepam rectal gel Hydrocodone containing products Hydromorphone Methadone Methylphenidate transdermal system(daytrana patch) Oxycodone containing products Oxymorphone Tapentadol
57
What must pharmacies do to participate in the **Pharmacy Take-Back Program**?
* Register with the DEA * Install a collection bin ## Footnote This program allows pharmacies to safely collect unwanted drugs from patients.
58
What are the requirements for a **collection bin** in pharmacies?
* Strong waterproof, removable liner * Rigid design * Securely locked ## Footnote These features ensure safe and secure disposal of medications.
59
Who is allowed to remove drugs from the **collection bin**?
Only the reverse distributor staff ## Footnote Pharmacy staff cannot access the contents of the bin.
60
What types of items **cannot** be placed in the collection bin?
* Sharps and needles * Illicit drugs ## Footnote These items pose additional risks and are not permitted in the disposal bin.
61
What notifications must be made to the board regarding drug take-back services?
* Establishment of service * Discontinuation of service * Tampering with a collection bin * Theft of deposited drugs * Tampering, damage, or theft of a removed liner * Disclosure of service and location of each receptacle ## Footnote These notifications ensure compliance and safety in drug disposal practices.
62
What is the **timeframe** for notifying the board about the establishment of a drug take-back service?
Within 30 days ## Footnote Timely notifications are crucial for regulatory compliance.
63
What is the timeframe for notifying the board about **tampering with a collection bin**?
Within 14 days ## Footnote Quick reporting helps address safety concerns promptly.
64
How many pharmacy staff MUST WATCH the removal and sign that they witnessed the disposal
2
65
T/F: controlled subs can be commingled with non controlled in the collection bin
True
66
T/F: pharmacies can use the collection bins to dispose of their own expired or recalled drugs
False
67
68
What is the purpose of the **pre-paid, pre-addressed mailing envelopes** provided by pharmacies?
To return drugs to an authorized destruction location ## Footnote The patient puts the medications into the envelope and drops off the package at the post office.
69
What features does the **package** for returning medications have?
* Waterproof * Spill-proof * Tamper-evident * Tear-resistant * Sealable ## Footnote The package has a unique identification number that enables tracking.
70
What is the name of the campaign by the California Board of Pharmacy to avoid water pollution?
Don't Rush to Flush ## Footnote The campaign aims to reduce risk associated with improper disposal of medications.
71
List the **three easy steps** for patients to safely dispose of unwanted drugs according to the Don't Rush to Flush campaign.
* Remove pills and solid medications from containers and consolidate in a clear plastic zipper bag * Obscure personal information from medication containers and recycle them * Bring zipper bag and liquids/creams to a Don't Rush to Flush location and place in the bin ## Footnote These steps help ensure safe disposal of medications.
72
Fill in the blank: Patients should dispose of drugs in the trash by mixing them with an undesirable substance such as _______.
kitty litter ## Footnote This makes the drug less appealing to children and pets, and unrecognizable to people intentionally searching through the trash.
73
What should patients do with drugs before disposing of them in the trash?
* Remove drugs from original containers * Mix with an undesirable substance * Place mixture into a sealable bag or empty container * Discard in the trash ## Footnote This method is recommended for drugs not on the FDA's Flush List.
74
Who are considered **mandated reporters** of child abuse, elder abuse, and neglect?
* Pharmacists * Intern pharmacists * Technicians ## Footnote These individuals are licensed by the board and have regular contact with vulnerable populations.
75
What should a mandated reporter do when they suspect **abuse or neglect**?
* Phone law enforcement * Phone protective services * Prepare and send a written report within two working days or 36 hours ## Footnote A report should be made when there is a reason to believe that a child or elder is a victim.
76
True or false: Failure to report suspected abuse or neglect is a misdemeanor punishable by up to six months in jail and/or a fine of $1,000.
TRUE ## Footnote Mandated reporters must act promptly to avoid legal consequences.
77
What is the time frame for sending a **written report** after receiving information about suspected abuse or neglect?
Within two working days or 36 hours ## Footnote Timely reporting is crucial for the protection of vulnerable individuals.
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