Hospital and Health Care Facilities

A health care facility is an organization that provides a physical environment for patients to obtain health care services such as a hospital, LTCF, a mental health facility, drug abuse treatment center, a penal institution or hospice.

T/F

All hospitals and health care facility pharmacies providing services involving the practice of pharmacy must register with the North Carolina Board of Pharmacy to receive a pharmacy permit.

TRUE

NOTE:

Healthcare facilities that ONLY administer drugs are exempt from registering with the North Carolina Board of Pharmacy similar to an outpatient surgical center.

What are THREE instances when separate pharmacy registrations/permits for dispensing drugs are required for healthcare facilities?

1. Drugs dispensed are obtained from a source outside of the healthcare facility.
2. Pharmacist manager is supervised from a source other than the health care facility pharmacy
3. Dispensing drugs to outpatients

If a hospital or healthcare facility is handling controlled substances, who must they be registered with?

NC Drug Control Unit

NOTE:

Community or retail pharmacies do not have to register with the NC Drug Control unit.

If a hospital or healthcare facility is handling controlled substances, how often must they renew their registration with the NC Drug Control Unit?

Annually

T/F

In a hospital or healthcare facility pharmacy, the pharmacy must be directed by a pharmacist manager who is fully aware of and responsible for all activities involved in the preparation and dispensing of medications.

TRUE

When discrepancies occur with controlled substance counts in a hospital or healthcare facility, Pharmacist Managers must report to which of following?

I. NC Board of Pharmacy

II. DEA

III. FDA

A. I only

B. I and II only

C. II and III only

D. I, II and III

B. I and II only

How soon shall discrepancies with controlled substance counts in a hospital or healthcare facility be reported to the Pharmacy Manager?

Within 24 hours

In a hospital or healthcare facility medications are dispensed only upon receipt of a medication order. Medication Orders in a Hospital or Heathcare Facility can be in written, oral, fax or electronic form.

NINE Elements of a Medication Order.

1. Date Written
2. Patient's Name and Location
3. Medication Name
4. Medication Strength
5. Medication Dosage Form
6. Route of Administration
7. Directions for Administration
8. Discernible Quantity (30-day supply)
9. Prescriber's Signature

NOTE:

There are no restrictions on the form of medication orders. Medication orders are not prescriptions.

In a hospital or healthcare facility medications are dispensed only upon receipt of a medication order. Medication Orders in a Hospital or Heathcare Facility can be in written, oral, fax or electronic form.

What do Medication Orders in a patient's profile contain?

1. Patient's Name and Location
2. Patient's age, sex, weight, height, allergies
3. Medication Name
4. Medication Strength
5. Medication Dosage Form
6. Route of Administration
7. Directions for Administration
8. Medication Start and Discontinuance Date
9. ID of Pharmacist or Verifying Tech Entry

T/F

In a hospital or healthcare facility medications orders can be given in oral form. Oral medication orders shall be recorded immediately and signed by the physician.

TRUE

In a hospital or healthcare facility which of the following are measures that can be taken to avoid indefinite open-ended medication orders?

I. Routine monitoring of patient's drug therapy by pharmacist

II. Automatic Stop Order Policy covering those medication orders that do not specify a number of doses or duration of therapy

III. Automatic Cancellation of all medication orders after a predetermined time interval.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

How often must healthcare facilities who credential practitioners for prescribing privileges provide the pharmacy with credentialling information for each practitioner?

Annually OR immediately if privileges are revoked

NOTE:

This lets the pharmacy know what practitioners are approved by the healthcare facility to write medication orders and see patients at that facility.

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Labeling Requirements for Medications in a Hospital or Healthcare Facility:

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Additional Labeling Requirements for Parenteral Admixtures:

1. Name of Drug Added
2. Amount of Drug Added
3. Expiration Date
4. Expiration Time

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Additional Labeling Requirements for Compounds:

1. ID of Person who prepared compound
2. ID of Pharmacist who verified compound
3. Expiration Date (BUD)
4. Storage Requirements
5. Appropriate Packaging and Labeling for Hazardous Materials

Auxiliary Medication Inventories contain drugs and devices only in amounts to meet immediate therapeutic needs of patients.

THREE Examples of Auxiliary Medication Inventories.

1. Patient Care Unit Medications
2. Ancillary Drug Cabinet
3. Emergency Kits

The pharmacist manager in consultation with the medical staff must develop a list of drugs and devices that may be stocked in Auxiliary Medication Inventories. These drugs shall be labeled.

What are the labeling requirements for drugs contained in Auxiliary Medication Inventories?

1. Drug Name
2. Drug Strength
3. Drug Lot#
4. Manufacturer
5. Expiration Date

When medications are taken out of the Auxiliary Medication Inventory. What must be recorded after withdrawal?

1. Date of Removal
2. Name, Strength, Dosage Form and Quantity
3. Name of Patient
4. Name or ID of Person who removed drug or device

Which of the following is designed to meet the immediate therapeutic needs of patients?

I. Emergency Kits

II. Patient Care Unit Medication Inventories

III. Ancillary Drug Cabinets Inventories

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

NOTE:

Auxiliary Medication Inventories

T/F
Auxiliary Medication Inventories must be used in a hospital or healthcare facility with a pharmacy permit.

TRUE

NOTE:

The ONLY exception is when being used as an emergency kit.

May controlled substances be kept in an auxiliary medication inventory?

A. Yes

B. No

A. Yes

NOTE:

Hospital or healthcare facility must make sure there is a record of these controlled substances.

Which of the following describes a mechanical system that performs functions relating to the storage, packaging, counting, labeling and dispensing of medications and collects, controls, and maintains all transaction information?

Automated Dispensing or Drug Supply Device i.e., Pyxis machine

NOTE:

Can also be used as an auxiliary medication inventory or emergency kit.

Medication orders need to be prospectively verified by the pharmacist before the nurse removes the drug from a automated dispensing device (pyxis machine).

What are THREE exceptions to this rule?

1. Override Medications
   • Medications used in an emergency.
2. Physician Controlled Medications
   • Medications administered under the direct supervision of a physician.
3. Subsequent Doses
   • Nurse can pull subsequent doses of a medication that is already verified by a pharmacist.

T/F

Automated Dispensing Devices may only be stocked by a pharmacist.

FALSE

Automated Dispensing Devices can be stocked by non-pharmacist personnel.

Automated Dispensing Devices can be stocked by non-pharmacist personnel.

Name THREE procedures that can be used for verification of stocking an Automated Dispensing Device.

1. Pharmacist conducts a DAILY AUDIT of medications placed into Automated Dispensing Device.
2. Using Bar code or Electronic Verification
   • Requires an initial and quarterly quality assurance by pharmacist.
3. Tech Check Tech (hospital pharmacies ONLY)
   • Allows a validating technician to verify other registered technicians in filling floor stock without verification from pharmacist

THREE Qualifications of Validating Technicians.

1. Registered with NC BOP
2. Certified Technician
3. Associate's Degree in Pharmacy Technology

Which of the following activities may a Validating Technician perform?

I. Stock of patient care unit medications

II. Stocking of ancillary drug cabinet inventories.

III. Stocking of automated dispensing or drug supply devices.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

Which of the following activities may a Validating Technician perform?

I. Stock of emergency kits

II. Validate the filling of floor stock and unit dose distribution systems.

III. Prepackaging of prescription drugs within the hospital pharmacy.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

Which of the following activities may a Validating Technician perform?

A. Prepackage medications

B. Stock Automated Dispensing Systems

C. Verify a patient-specific medication order

D. A & B

E. All of the above

D. A & B

NOTE:

Verifying a patient-specific drug order can only be done by a pharmacist.

How long shall transaction records (non-controlled and controlled medications) distributed by an Automated Dispensing Devices be kept?

3 years

T/F

Medication reuse from an Automated Dispensing Device is permissible.

TRUE

NOTE:

As long as the drug's purity, packaging and labeling have been examined, and it has been approved.

T/F

Automated Dispensing Devices must be used in a facility with a pharmacy permit.

TRUE

NOTE:

If NOT, it can ONLY be used as an emergency kit.

In Summary Describe an Auxiliary Medication Inventory.

1. Immediate Therapeutic Needs of Patients (Emergency Situations)
2. Location outside of the Pharmacy
3. Nurse pulls medication WITHOUT a prescription order (MD must provide prescription order after emergency)
4. Examples: Floor stock, Drug cabinets, emergency kits

In Summary Describe an Automated Dispensing Device.

1. Can function as an Auxiliary Medication Inventory
2. Location outside of the Pharmacy
3. MD writes a prescription order, pharmacist verifies, and nurse pulls medication and subsequent doses.
4. Examples: Pyxis and MedStation

The emergency department staff is complaining about the long time it takes the pharmacy to deliver certain medications during a code situation. Which of the following ways could the pharmacy improve their turn around time?

A. Install an Auxiliary Medication Inventory such as a drug cabinet

B. Install an Automated Dispensing Device such as a Pyxis machine

C. Both of the above

D. Neither of the above

C. Both of the above

NOTE:

Auxiliary Medication Inventory is used to meet immediate therapeutic needs, however an Automated Dispensing Device can also be used as an Auxiliary Medication Inventory.

Which of the following would be appropriate for a hospital pharmacy to install in order to quickly dispense patients' maintenance medications (i.e Metformin)?

A. Auxiliary Medication Inventory such as a drug cabinet

B. Automated Dispensing Device such as a Pyxis machine

C. Both of the above

D. Neither of the above

B. Automated Dispensing Device such as a Pyxis machine

NOTE:

This is not for the immediate therapeutic need of a patient; therefore, Auxiliary Medication Inventory would not be appropriate.

Repackaging in a Hospital or Healthcare Facility Pharmacy

T/F
Hospital or healthcare facilities must register as a "Repackager" to repacking medications.

FALSE

Hospital or healthcare facilities DO NOT NEED TO register as a "Repackager" to repacking medications.

Labeling Requirements for Repackaged Medications.

1. Generic or Trade Name
2. Drug Quantity
3. Drug Strength
4. ID of Manufacturer
5. Lot or Control #
6. Expiration Date
7. Cautionary Notations
8. Batch # (instead of manufacturer and lot #)

NOTE:

Repackaging should be performed by or under the supervision of a pharmacist.

Absence of a Pharmacist at a Hospital or Healthcare Facility

In a healthcare facility a pharmacy is not open 24 hours a day, 7 days a week, arrangements need to be made for the provision of drugs and pharmaceutical care.

What are the TWO options that the pharmacist-manager has to assure access to drugs in the absence of a pharmacist?

1. Remote Order Entry: Contract with another health care facility, pharmacy, or pharmacy
2. Authorize and train a nurse to remove the drugs from the pharmacy during the absence

In absence of a pharmacist in a hospital or health care facility a nurse may be authorized to remove drugs from the pharmacy if... SATA

A. Drug needed is not in auxiliary medication inventory'

B. "On call" pharmacist is accessible

C. Pharmacist maintains a list of authorized persons and documents the initial orientation, continuing education and quality control process.

D. Pharmacist maintains a list of restricted medications that may not be removed from the pharmacy.

A. Drug needed is not in auxiliary medication inventory'

B. "On call" pharmacist is accessible

C. Pharmacist maintains a list of authorized persons and documents the initial orientation, continuing education and quality control process.

D. Pharmacist maintains a list of restricted medications that may not be removed from the pharmacy.

Which of the following are requirements for a nurse to remove medications from the pharmacy during the times a hospital pharmacy is not open? SATA

A. Nurse must contact "on call" pharmacist for all medications removed

B. Nurse must receive adequate training for removing medications from the pharmacy.

C. All medications can be removed by a nurse from the pharmacy.

D. Medication must be pre-labeled by a pharmacist.

A. Nurse must contact "on call" pharmacist for all medications removed

B. Nurse must receive adequate training for removing medications from the pharmacy.

D. Medication must be pre-labeled by a pharmacist.

NOTE:

Drugs must be pre-labeled by the pharmacist with the drug name, strength, lot # and expiration date.

If a nurse removes a medication from a hospital pharmacy during the absence of a pharmacist, within how many hours must a pharmacist obtain and verify a medication order?

A. 24 hours

B. 48 hours

C. 72 hours

D. 96 hours

A. 24 hours

How long shall a record of medications removed from auxiliary medication inventories or from pharmacy inventory be kept?

3 years

How often shall the pharmacist-manager verify the accuracy of the records of medications removed?

Quarterly

T/F

Supportive personnel may work in the pharmacy during the absence of a pharmacist.

TRUE

NOTE:

To perform clerical, repackaging and distributive functions. Drugs may leave the pharmacy ONLY if checked by a pharmacist.

T/F
Controlled substances cannot be stocked and removed from auxiliary medication inventories. Controlled substances cannot be removed from the pharmacy in the absence of a pharmacist.

FALSE

Controlled substances MAY be stocked and removed from auxiliary medication inventories. Controlled substances CANNOT be removed from the pharmacy in the absence of a pharmacist.

In a hospital or healthcare facility pharmacy the responsible pharmacists and pharmacy technicians for medication compounding and dispensing must be recorded and identified.

How long must these records be kept?

30 days

In a hospital or healthcare facility a Pharmacist-Manager shall document medication errors resulting from the administration of an incorrect medication or dose.

How long shall these records be kept?

3 years

In a hospital or healthcare facility a Pharmacist-Manager shall retain all documents, labels, vials, supplies, substances, and internal investigation reports relating to an event where a prescription drug has caused or contributed to death of a patient.

How long shall these records be kept?

3 years

NOTE:

When a patient dies as a result of a medication error it must be reported to the NC Board of Pharmacy within 14 days.

In a hospital or healthcare facility a Pharmacist-Manager shall maintain records of ordering, receiving, dispensing, or transfer of controlled substances.

How long shall these records be kept?

3 years

T/F
An automated system may be used to keep the records regarding controlled substances dispensed to patient if the original medication order and dispensing history can be immediately retrieved.

TRUE

How soon must records from a hospital or healthcare facility be available to the NC Board of Pharmacy?

Within 48 hours

T/F

All hospital records must be kept for 3 years.

FALSE

Day to day records that identify the responsible pharmacist and pharmacy technician for medication compounding and dispensing must be kept for 30 days.

Health Care Facility Emergency Departments are permissible to dispense medications to patients of emergency departments and for patients to take home.

Labeling Requirements for Medications Dispensed from ED.

1. Healthcare Facility Name
2. Healthcare Facility Address
3. Healthcare Facility Phone #
4. Patient Name
5. Physician Name
6. Dispensing Date
7. Product Name
8. Directions for use
9. Precautionary Statements

Which of the following are TRUE regarding medications being dispensed from a healthcare facility emergency department?

I. A prescription needs to be issued from a practitioner.

II. Patient is required to be counseled.

III. If a 24-hour outpatient pharmacy is not available a prescription may be dispensed and is limited to not more than a 48-hour supply or the smallest commercially available quantity.

A. I only

B. I and II only

C. II and III only

D. I, II and III

B. I and II only

NOTE:

If a 24-hour outpatient pharmacy is not available a prescription may be dispensed and is limited to not more than a 24-hour supply or the smallest commercially available quantity.

How long should a Perpetual Record of all dispensed drugs be maintained with pharmacy records?

3 years

In a Hospital and Healthcare Facility Pharmacy the Perpetual Record should contain.

1. Date Dispensed
2. Patient's Name
3. Physician's Name
4. Drug Name
5. Drug Strength
6. Drug Dosage Form
7. Drug Quantity
8. Drug Dose

How often shall a Pharmacist-Manager of a hospital or healthcare facility pharmacy verify the accuracy of a Perpetual Record?

Monthly

Medication orders in health care facilities, without a quantity indicated on the order, should be limited to which of the following day supply?

A. 7 days

B. 15 days

C. 30 days

D. 60 days

Long Term Care Facilities

T/F

An automated dispensing device can be installed in a LTCF by a retail pharmacy registered with the DEA.

LTCFs are allowed to have controlled substances in an automated dispensing device.

TRUE

NOTE:

ONLY if registered with the DEA. If not registered with the DEA LTCFs may not order or maintain stocks of controlled substances.

T/F

The retail pharmacy that installs the Automated Dispensing Device must maintain a separate DEA registration at the LTCF location.

TRUE

NOTE:

Retail Pharmacy may keep records of the Automated Dispensing Device at their pharmacy.

T/F
A pharmacy permit is required from the NC Board of Pharmacy in order to have an Automated Dispensing Device at the LTCF.

TRUE

NOTE:

Can apply for a Limited-Service Permit.

T/F

A pharmacy can place an emergency kit with controlled substances in a non-DEA registered LTCF.

TRUE

NOTE:

The pharmacy is responsible for the emergency kit and must be registered with the DEA. Therefore, it is considered an extension of the pharmacy and is covered under the pharmacy's DEA registration. A separate DEA registration is not needed. unlike when a pharmacy placed an Automated Dispensing Device in a LTCF that contains controlled substances.

How many controlled substances can be contained in an Emergency Kit within a LTCF?

7 Controlled Drug Entities (C-II through C-V)

• No more than 5 doses of each drug entity for each 50 licensed beds

What must be established for a LTCF nurse or employee to be an agent of the patient's prescriber?

Written agreement

LTCF Agents of a Prescriber (LTCF nurse or employee) may perform which of the following tasks?

I. Call in an emergency oral C-II prescription to the pharmacy

II. Transmit a fax prescription for all controlled (including C-II) and non-controlled substances from the prescriber.

III. Prepare a written prescription for the signature of the practitioner.

A. I only

B. I and II only

C. II and III only

D. I, II and III

C. II and III only

NOTE:

Agents of a prescriber at a LTCF can ONLY call in a prescription for non-controlled substances and CIII, CIV and CV to the pharmacy.

Nuclear Pharmacy (Not Completed)

How many hours of TRAINING must a NUCLEAR Pharmacist receive?

1. 200 hours of didactic training
2. 500 hours of training under a licensed nuclear pharmacist

Label Affixed to the Immediate INNER Container of Radiopharmaceutical,

1. Radiation Symbol
2. "Caution Radioactive Material"
3. Radionuclide and chemical form
4. Amount of radioactivity
5. Expiration date and time
6. Name of Procedure
7. Prescription Number
8. Pharmacy Name

Label Affixed to the Immediate OUTER Container of Radiopharmaceutical,

1. Radiation Symbol
2. "Caution Radioactive Material"
3. Radionuclide and chemical form
4. Name of Procedure
5. Prescription/LOT #
6. Pharmacy Name and Address
7. Prescriber Name
8. Date of Dispensing
9. Amount of Radioactivity
10. Expiration Date
11. Expiration Time
12. If liquid - Volume
13. If a gas - ampules, vials, or syringes
14. If a solid - weight
15. USP limits
16. Physician Use Only