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NJ MPJE > Health Care Facilities & Instituitional Pharmacies > Flashcards

Health Care Facilities & Instituitional Pharmacies Flashcards

1
Q

An institutional pharmacy filling prescriptions for outpatient use shall…

A

comply with all retail pharmacy requirements of this chapter

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2
Q

“Drug administration” means…

A

a procedure in which a prescribed drug is given to a patient by an authorized person in accordance with all laws and rules governing such procedures.

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3
Q

“Formulary” means…

A

a continually revised compilation of pharmaceuticals available in the pharmacy for use in the facility developed by the P&T Committee.

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4
Q

“Health care facility” means…

A

a facility or institution licensed by the Department of Health pursuant to N.J.S.A. 26:2H-1 et seq.

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5
Q

“Health care system” means…

A

one or more health care facilities that are owned or controlled by the same legal entity.

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6
Q

“Institutional pharmacy” means…

A

the area in a health care facility or a health care system licensed by the Board as a pharmacy that maintains an institutional permit.

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7
Q

“Institutional pharmacy” includes any areas of the health care facility or the health care system where…

A

pharmaceuticals are stored, compounded or dispensed.

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8
Q

“Medication order” means…

A

a written request for medication originated by a practitioner and intended for patient use in the health care facility, and not for use of the institution’s employees or their dependents or outpatients of the facility’s clinics

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9
Q

A valid medication order contains the…

A

date ordered, the patient’s name and location within the facility, the name, dose, route, and frequency of administration of the medication, and any additional instructions

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10
Q

Computerized signatures or passwords will be accepted provided that the facility has adequate safeguards which assure the…

A

confidentiality of each electronic signature or password and which prohibit their improper or unauthorized use.

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11
Q

“Pharmacy and Therapeutics Committee” means the…

A

active standing committee of the institution or health care facility which is the organizational line of communication and liaison between the medical service and pharmacists and which acts to review and promote rational drug therapy and utilization in the facility.

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12
Q

“Unit dose packaging” means a…

A

a single unit use non-parenteral medication provided in packaging which contains the following information for each unit in the package:

1) Product name;
2) Strength and/or quantity and/or volume, where appropriate;
3) Lot number;
4) The phrase “use by” followed by the product’s use by date.
i) For purposes of this paragraph, “use by date” means the earlier of one year from the date of packaging or the expiration date on the manufacturer’s container;
c) Manufacturer or repackager; and
d) If there is more than one product in the single unit, a physical description of each medication in the single unit.

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13
Q

Any institutional pharmacy as defined under N.J.A.C. 13:39-9.2 shall be…

A

registered with and possess an institutional permit issued by the Board. The permit shall be conspicuously displayed in the facility’s pharmacy. The institutional pharmacy is subject to and shall be conducted in accordance with all existing State and Federal rules and regulations.

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14
Q

An institutional permit is required…

A

for any area within an institution serviced by an outside vendor that performs on-site pharmaceutical services as defined in N.J.A.C. 13:39-1.2.

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15
Q

The pharmacist-in-charge, or designee, shall be…

A

an actively participating member on any committees of the facility that may be concerned with drugs and their utilization.

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16
Q

In all health care facilities providing pharmaceutical services to patients, an active standing committee of the institution entitled the Pharmacy and Therapeutics Committee or another appropriate name shall be…

A

established if required pursuant to Department of

Health rules. A Pharmacy and Therapeutics Committee shall be multidisciplinary and include a pharmacist.

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17
Q

In all health care facilities providing pharmaceutical services to patients that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health rules, the pharmacist-in-charge of the provider pharmacy, in cooperation with the
health care facility, shall…

A

create policies and procedures as needed to provide
pharmaceutical services to the health care facility. Copies of the policies and procedures shall be made available to the Board upon request.

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18
Q

The pharmaceutical services of the health care facility shall be…

A

the responsibility of and under the control, supervision, and direction of the pharmacist-in-charge of the provider pharmacy

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19
Q

If a health care facility does not have an institutional pharmacy on its premises or chooses to utilize the services of a pharmacy outside the health care system, it may…

A

enter into an agreement with a retail pharmacy licensed by the Board. The PIC of the retail pharmacy shall direct, control, supervise and be responsible for the pharmaceutical services provided to the facility.

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20
Q

The PIC of the provider pharmacy, with the cooperation of the Pharmacy and Therapeutics Committee, shall…

A

develop written policies and procedures as
needed to provide pharmaceutical services to the facility. The written policies and procedures shall be available to the Board.

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21
Q

The PIC shall be…

A

responsible for determining the specifications for
drugs and pharmaceutical preparations used in the treatment of patients of the facility as to quality, quantity and source of supply. An authorized purchasing agent and/or materials manager and/or pharmacy buyer of the facility may perform the actual
procurement. All purchases shall be reviewed by the PIC or his or her designee, who shall be a pharmacist.

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22
Q

Written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility shall be…

A

developed by the PIC and approved by the P&T Committee

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23
Q

Written policies and procedures for the control, use and accountability of controlled dangerous substances shall be…

A

developed by the PIC and the P&T Committee. Controlled dangerous substances shall be purchased, received, stored, dispensed, administered, recorded and controlled in accordance with State and Federal laws and regulations

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24
Q

The pharmacist shall…

A

review the practitioner’s original order or a copy of the original order generated by any media that facilitates the reproduction of the original order before any initial dose of medication is dispensed, except as provided for in N.J.A.C. 13:39- 9.13.

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25
Q

Drugs not specifically limited as to time or number of doses when ordered shall be…

A

controlled by the automatic stop order procedure or other methods in accordance with written policies of the facility

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26
Q

The Pharmacy and Therapeutics Committee shall…

A

develop a list of unapproved or unacceptable abbreviations and symbols that shall not be used in the facility. Orders involving symbols or abbreviations shall only be dispensed consistent with this list.

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27
Q

When appropriate, the pharmacist shall…

A

make necessary entries into the patient medical
record relative to drug use in accordance with health care facility policies and, where applicable, pursuant to regulations of the Department of Health and/or Centers for Medicare and Medicaid Services

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28
Q

A pharmacist shall…

A

receive oral orders only from an authorized practitioner. Such orders shall be immediately recorded and signed by the person receiving the order on the medication order sheet or into the electronic data processing system.

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29
Q

Oral orders for Schedule II controlled substances shall be…

A

permitted only in the case of a bona fide emergency situation.

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30
Q

Oral orders received consistent with the requirements of (b) and (c) above shall be…

A

countersigned by the practitioner.

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31
Q

The pharmacist may release to the patient at discharge any remaining medication in a multiple-dose container (for example, inhalers, multiple-dose injectable medications, such as insulin, topical preparation, drops, ointments and topical irrigation solutions), and a limited supply of other medications provided that the pharmacist:

A

1) Labels the medications for out-patient use pursuant to labeling requirements set forth
in N.J.A.C. 13:39-7.12;
2) Counsels the patient prior to discharge from the hospital or medical facility pursuant
to N.J.A.C. 13:39-7.21; and
3) Ensures that discharge orders contain the attending physician’s authorizations to dispense the remaining doses of the prescription or the limited supply of other
medications to the patient or guardian.

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32
Q

The pharmacist shall be responsible for monitoring drug therapy of patients in the facility. This shall include, but is not limited to:

A

maintaining and reviewing the patient medication

profile prior to the dispensing of medications.

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33
Q

In instances involving the issuance and administration of STAT orders (orders requiring immediate attention) these drugs shall be:

A

be documented on the patient’s medication profile

immediately after dispensing.

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34
Q

When the pharmacy is closed, drugs for STAT orders shall be:

A

documented on the patient’s medication profile immediately after the pharmacy is reopened.

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35
Q

The pharmacist shall be responsible for:

A

providing medication in a form that requires little or
no further alterations, preparation, reconstitution, dilution or labeling by other licensed personnel. The pharmacist shall provide adequate instructions for those products that are not dispensed in finished form.

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36
Q

Labeling of medications, other than intravenous solutions, shall be:

A

conformance with written policies and procedures controlling the drug distribution system in use within the facility and in accord with current acceptable standards of pharmaceutical practice. Labeling of
intravenous solutions shall be consistent with the labeling requirements set forth in N.J.A.C. 13:39-11.

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37
Q

No drugs shall be administered to a patient except those:

A

provided through the pharmacy or as provided by written policies and procedures developed by the PIC or, where applicable, the director of pharmaceutical services and approved by the P&T Committee.

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38
Q

Although the use of patient’s own medications may be warranted in certain situations, it should be discouraged as a general or routine practice. If a patient’s previously acquired medication is to be used:

A

a written order to this effect shall be signed and dated by the patient’s physician. Such medications shall be identified by the pharmacist as to contents
and dispensing origin. Also, these medications shall be documented as part of the pharmacy’s patient profile record system.

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39
Q

Where the use of a drug-dispensing device is approved as an integral part of the drug distribution system by the facility, the PIC and the P&T Committee, the device may be used when:

A

the pharmacist is not on duty (absent during either the day or night), provided that any absence of the pharmacist does not exceed 24 hours, or when the pharmacist is on duty, provided that proper review of
the use of the drug-dispensing device can be ascertained. The supervision of any drug
dispensing device so utilized shall be the responsibility of the PIC servicing the health care facility.

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40
Q

Packaging and labeling of medication for drug-dispensing devices, when done by the pharmacy, shall be:

A

performed under the immediate personal supervision of a pharmacist in the employ of or under contract to the facility.

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41
Q

Stocking of the drug-dispensing devices with prepackaged medications shall be:

A

performed by or under the supervision of a pharmacist.

42
Q

The drug-dispensing device data shall be checked for

accuracy every:

A

24 hours by a pharmacist and so documented.

43
Q

The cleanliness of the drug dispensing devices shall be:

A

maintained by a pharmacist or by a person under the supervision of a pharmacist

44
Q

Packaging and labeling of medication for drug-dispensing devices, when done by the pharmacy, shall be:

A

performed under the immediate personal supervision of a pharmacist in the employ of or under contract to the facility.

45
Q

Stocking of the drug-dispensing devices with prepackaged medications shall be:

A

performed by or under the supervision of a pharmacist.

46
Q

Controlled substances and other medications to which, in the professional judgment of the PIC, access should be limited, shall be:

A

secured within the drug dispensing device to limit access to single medications only and shall be checked and documented by the pharmacist or his or her designee who shall be a licensed health care
professional every 24 hours

47
Q

Other than a pharmacist, only authorized registered

nurses, licensed practical nurses, practitioners, pharmacy technicians, interns and externs shall have:

A

access to the medication in each drug-dispensing device. The activity regarding all medication, including the identity of the person accessing the medication,
shall be recorded and available to the pharmacist

48
Q

All medications withdrawn from a drug dispensing device require a medication order by an authorized practitioner. All such medication orders shall be:

A

checked by the pharmacist within 24 hours from the time of the original order and so noted on the
pharmacy’s patient medication profile

49
Q

When there is no pharmacy on the premises and when the drug-dispensing devices are an integral part of the approved drug distribution system of the facility, the devices shall be:

A

controlled by the PIC who is responsible for the pharmaceutical services of the institution. Under these circumstances, the time between medication
order checks shall not exceed 24 hours.

50
Q

Written policies and procedures governing unused medications shall be established and implemented by the PIC and shall comply with the following requirements:

A

1) All medications where the drug source, lot or control number, or expiration or use by date are missing, shall be sent to the pharmacy for final disposition, or shall be disposed of by the health care facility according to its written protocol.
2) If a unit dose packaged medication has been stored in a medication room or secure area in the institution and the medication seal and control number are intact, the medication may be recycled and redispensed.
3) Any and all medication returned by out-patients of the facility shall not be redispensed.
4) The record of the disposal of unused or nonadministered dispensed controlled dangerous
substances expended or wasted either by accident or intent shall be signed and cosigned and witnessed by a licensed nurse, physician, or pharmacist, or where
allowed by Department of Health rules an administrator of the health care facility, and
disposed of by the health care facility according to its written protocol and consistent with all local, State, and Federal laws and regulations.

51
Q

Records of the pharmaceutical services of the provider pharmacy for the facility shall be:

A

the responsibility of the PIC

52
Q

The pharmacy shall maintain a patient profile record for each patient receiving drug therapy in accordance with N.J.A.C. 13:39-7.19 and as follows:

A

1) The profile records for inpatients shall contain: the date of each entry; the name; sex; age or birthdate; location of the patient; the drug name, dose, route of administration and quantity dispensed; the reported diagnosis, allergies and chronic condition(s) of
the patient.
2) All notations made on the inpatients’ profile records by pharmacy technicians, interns, and externs shall be verified and countersigned, either manually or electronically, by the supervising pharmacist.
3) The inpatient profile record shall be filed and stored for 5 years following patient discharge. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day.

53
Q

All outpatient prescriptions dispensed and outpatient profile records in the institutional pharmacy shall:

A

conform to the requirements set forth in N.J.A.C. 13:39-7.6

54
Q

Records for receipt, use and final disposition of controlled dangerous substances shall be:

A

maintained by the institutional pharmacy in compliance with the requirements of Federal and State-controlled dangerous substances laws and regulations. Nursing administration and audit records for controlled dangerous substances shall be available for review by the pharmacy.

55
Q

Records of the receipt, dispensing and disposal of investigational drugs shall be:

A

maintained by the institutional pharmacy in compliance with Federal and State laws and regulations

56
Q

The PIC shall be responsible for:

A

maintaining a system by which all reported adverse drug reactions are recorded and reviewed by the P&T Committee, where applicable, and are submitted to all appropriate State and local agencies consistent with State and local laws and regulations.

57
Q

The PIC shall be responsible for maintaining:

A

drug standards, references and sources of drug information current and adequate to meet the needs of the pharmacists, physicians, nurses, other health care personnel, and patients of the facility. Reference texts shall include, but not be limited to, those required by the Board under N.J.A.C. 13:39-5.8.

58
Q

On each patient care unit, the pharmacist shall maintain the following:

A

1) A copy of the current institutional formulary;
2) A reference drug compendium which will give basic information concerning drugs approved by the P&T Committee; and
3) The telephone number of either the local or regional poison control center.
c) The pharmacist shall participate in the drug education programs of the facility.

59
Q

Only a pharmacist shall have access to:

A

the pharmacy stock of controlled dangerous substances in Schedules II through V.

60
Q

Only a pharmacist shall have access to the institutional pharmacy except that in a pharmacist’s absence from an institution:

A

a registered nurse designated by the registered
pharmacist-in-charge may obtain medication from the hospital pharmacy as needed in an emergency and not available as floor stock.

61
Q

After hours, a designated registered nurse shall remove only those medication doses which shall be
administered prior to the opening of the pharmacy. The designated registered nurse may remove the following from the pharmacy stock of drugs or automated dispensing device:

A

1) A drug in its original container or a drug prepackaged by the pharmacy for use in the institution;
2) The required dose(s) of a drug from the original container for a specific patient

62
Q

The PIC shall obtain from the registered nurse on a suitable form a record of any drugs removed showing the following:

A

1) The name of the drug;
2) The dosage size;
3) The amount taken;
4) The date;
5) The patient’s name and location; and
6) The signature of the nurse

63
Q

The pharmacist-in-charge shall obtain with the record from the nurse above the:

A

container from which the required dose(s) was taken for drug administration purposes in order that it
may be properly checked by a pharmacist.

64
Q

All records in (d) above shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy, and shall be kept by the pharmacy for:

A

5 years. The oldest 4 years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent
one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

65
Q

Adequate facilities (space, lighting, equipment, temperature control and supplies) shall be:

A

provided for the control of the professional, technical and administrative functions of the institutional pharmacy as needed for the effective and efficient assurance of patient safety through proper purchasing, receipt, storage, dispensing, administration and
control of drugs.

66
Q

Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility.

A

1) All drugs shall be secured for safe use and protected against illicit diversion. Controlled dangerous substances in the institutional pharmacy and throughout the facility shall be stored and protected in conformance with State and Federal laws and regulations.
2) Supplies of external preparations stored in patient care areas shall be kept separate from internal medications.
3) The PIC or, where provided for in Department of Health rules, the director of pharmaceutical services shall be responsible for all the medications in the
facility.
4) The drugs throughout the facility shall be maintained under adequate storage conditions including proper lighting, ventilation and temperature control as required by N.J.A.C. 13:39-5.7(b).

67
Q

The PIC or, where provided for in Department of Health rules, the director of pharmaceutical services shall:

A

establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility

68
Q

Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least:

A

once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security and accountability of all drugs.

69
Q

These inspections shall be fully documented. Written inspection reports shall be prepared and:

A

signed by the inspecting pharmacist or by the pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist.

70
Q

The PIC shall be:

A

responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns and externs are trained and can successfully demonstrate competency

71
Q

Procedures for the review of these reports shall be:

A

developed and instituted by the PIC and can be incorporated into the overall quality assurance program of the health care facility

72
Q

Procedures shall be established to:

A

assure the immediate and efficient removal of all

outdated and recalled drugs from patient care areas and from the active stock of the pharmacy

73
Q

The PIC shall:

A

develop written policies and procedures governing the removal from the facility of outdated or recalled drugs

74
Q

Adequate equipment shall be:

A

provided for the compounding, packaging, labeling,

refrigeration, sterilization, testing and safe distribution of drugs and other functions

75
Q

An institutional decentralized pharmacy or a “satellite pharmacy”, means:

A

an area within a health care system that has been issued an institutional permit and is in a location other
than the original permitted location, where the preparation or dispensing or compounding of medications is performed.

76
Q

Medication shall not be:

A

dispensed from a decentralized pharmacy without a pharmacist present, except that, when the decentralized pharmacy is closed, a licensed nurse may dispense medication in accordance with the written policies and procedures of the institution.

77
Q

Institutions operating decentralized pharmacies shall:

A

notify the Board, in writing, of the existence of, and the discontinuation of, each decentralized pharmacy location

78
Q

Institutional decentralized pharmacies shall be:

A

subject to normal Board inspections.

79
Q

Inspections of all medications in a decentralized institutional pharmacy shall be:

A

performed consistent with the requirements of N.J.A.C. 13:39-9.23.

80
Q

Institutional decentralized pharmacies shall:

A

comply with all requirements in this subchapter applicable to the pharmaceutical services provided by the decentralized pharmacy, as determined by the PIC.

81
Q

Only medication orders issued by a practitioner licensed to write medication orders in the United States or any territory of the United States shall be:

A

considered valid medication orders and such medication orders shall be filled pursuant to NJ law.

82
Q

Medication orders, other than those listed in (a) above, shall not:

A

be filled by a pharmacy in NJ

83
Q

A pharmacist may, subject to the conditions set forth in this section, accept for dispensing a prescription or a medication order transmitted by:

A

a facsimile (FAX) machine or other technological device as approved by the Board.

84
Q

A pharmacist filling prescriptions under an institutional permit for employees of the institution and their dependents and for eligible outpatients may:

A

accept for dispensing prescriptions for all substances consistent with the requirements of N.J.A.C. 13:39-7.10
and 7.11.

85
Q

A pharmacist who is authorized to fill inpatient medication orders, as defined in N.J.A.C. 13:39-9.2, in an institutional pharmacy may:

A

accept all inpatient medication orders, including orders for Schedule II substances, which have been transmitted by technological device

86
Q

Whenever a pharmacist has reason to question the accuracy or authenticity of a Rx or medication order transmitted by technological device, the pharmacist shall:

A

verify the transmission directly with the prescribing practitioner.

87
Q

It shall be deemed professional misconduct for a pharmacist to use a technological device in order to:

A

circumvent his or her responsibilities with regard to documenting, authenticating and verifying medication orders and prescriptions or in order to circumvent
other standards of pharmacy practice.

88
Q

No licensee or permit holder registered under N.J.S.A. 45:14-40 et seq. shall:

A

under any circumstances provide a technological device to, or accept a technological device from,
any practitioner licensed to write prescriptions.

89
Q

No licensee or permit holder shall:

A

enter into any agreement with an authorized practitioner which denies the patient the right to have his or her prescription transmitted by the technological device to a pharmacy of the patient’s choice.

90
Q

As used in this subchapter, “automated medication system” means:

A

any process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing and distribution of medications, and which collects, controls and
maintains all transaction information. “Automated medication system” does not mean an automatic counting device

91
Q

Prior to use for the first time of an automated medication system, the pharmacy shall:

A

conduct and submit to the Board a self-inspection of the automated medication system documented on a form provided by the Board. After receipt of the self-inspection, the Board shall conduct an inspection of the automated medication system.

92
Q

A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that the pharmacy:

A

1) Conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. The pharmacy shall make the self-inspection available to the Board upon request;
2) Tests the automated medication system consistent with N.J.A.C. 13:39-10.6. The pharmacy shall make the results of such testing available to the Board upon request; and
3) Makes the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the self-inspection and/or of the system.

93
Q

The PIC shall be responsible for the following:

A

1) Supervision of the operation of the system, or in the case of an automated medication system utilized at a location with no on-site pharmacy, the PIC of the provider pharmacy shall be responsible for the supervision of the operation of the system;
2) Ensuring that there are written policies and procedures, which are reviewed and
approved by the PIC for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access, and malfunction, and ensuring compliance with such policies and procedures;
3) Ensuring that the pharmacy conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. Such inspection shall verify that the automated medication system has been tested by the pharmacy and found to dispense accurately;
4) Ensuring that medications in the automated medication system are inspected, at least once every two months, for expiration or use by date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least once every two months, for security and accountability;
5) Assigning, discontinuing or changing personnel access to the automated medication system;
6) Ensuring that the automated medication system is stocked accurately and an accountability record is maintained in accordance with the written policies and
procedures of operation; and
7) Ensuring compliance with all applicable provisions of N.J.A.C. 13:39.

94
Q

When an automated medication system is used to fill prescriptions or medication orders it shall be:

A

operated according to written policies and procedures of operation. The policies and procedures of operation shall:
1) Include a table of contents;
2) Include a description of all procedures of operation;
3) Set forth methods that shall ensure retention of each amendment, addition, deletion, or other change to the policies and procedures of operation for at least 2 years after the change is made. Each such change shall be signed or initialed by the PIC and shall include the date on which the PIC approved the change;
4) Set forth methods that shall ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the
transmission is made;
5) Set forth methods to identity the quality control measures in place to ensure the accuracy of the final dispensed product;
6) Set forth methods that shall ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records, for the purpose of complying with N.J.A.C. 13:39-7.19;
7) Set forth methods that shall ensure that access to the automated medication system for stocking and retrieval of medications is limited to licensed practitioners or qualified pharmacy technicians, interns and externs under the supervision of a pharmacist. An accountability record, which documents all transactions relative to stocking and removing medications from the automated medication system shall be maintained; and
8) Identify the circumstances under which medications may be removed from the automated medication system by a licensed practitioner for distribution to a patient without prior order review by a pharmacist.

95
Q

A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall:

A

at least annually, review its written policies and procedures of operation and revise them if necessary.

96
Q

A copy of the written policies and procedures of operation adopted pursuant to this section shall be:

A

retained at the pharmacy and at the healthcare facility where the automated medication system is utilized. Upon request, the pharmacy shall provide to
the Board a copy of the written policies and procedures of operation for inspection and
review.

97
Q

The PIC shall be responsible for ensuring that:

A

prior to performing any services in connection with an automated medication system, all pharmacists and pharmacy technicians, interns and externs are trained in the pharmacy’s standard operating procedures
with regard to automated medication systems as set forth in the written policies and procedures
of operation maintained pursuant to N.J.A.C. 13:39-10.4.

98
Q

A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall:

A

operate according to a written program for quality assurance of the automated medication system which:
1) Requires continuous monitoring of the automated medication system;
2) Establishes mechanisms and procedures to test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system;
3) Establishes a protocol for measuring the effectiveness of the automated medication
system;
4) Requires the pharmacy to report to the Board each recurring error of the automated medication system. A “recurring error,” for purposes of this section, means any specific type of inaccuracy within the automated medication system that occurs more than twice within a 14 day period; and
5) Requires the pharmacy to maintain all documentation relating to the written program for quality assurance for at least 2 years.

99
Q

A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall:

A

maintain a written plan for recovery from a disaster which interrupts the ability of the pharmacy to provide services. The written plan for recovery shall include:
1) Planning and preparation for a disaster;
2) Procedures for response to a disaster;
3) Procedures for the maintenance and testing of the written plan for recovery; and
4) A procedure to notify the Board, each organization that has contracted with the pharmacy, each patient of the pharmacy, and other appropriate agencies, of a
disaster and the date on which the pharmacy expects to recommence the provision of service.

100
Q

A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall maintain a:

A

written program for preventative maintenance of the system.

NJ MPJE (15 decks)

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