Ch 19 P 6 Pharmacies

Question 1

Contracted

Answer 1

Having a written agreement (to include” business associate agreements” as required by federal law) between parties to ensure the authenticity and prescribing authority of each prescriber transmitting prescriptions, sufficient security to prevent the fraudulent creation or alteration of prescriptions by unauthorized parties, and assurance that “network vendors” or electronic prescription transmission intermediaries involved in the transmission and formatting of the prescription can provide documentation of chain of trust of who has had access to prescription content. Electronic prescription transmissions by non “contracted” parties will be invalid.

Question 2

Drug utilization review (DUR)

Answer 2

Evaluating or reviewing the patient record in order to determine the appropriateness of the drug therapy for a patient and which includes the prospective drug review in 16.19.4 NMAC and the verification of data entries including the correct interpretation and input of written prescriptions and the drug regimen review (Subsection L of Section 61-11-2 NMSA 1978) as required by the board.

Question 3

Electronically transmitted prescriptions

Answer 3

Communication of original prescriptions, refill authorizations, or drug orders, including controlled substances to the extent permitted by federal law, from an authorized licensed prescribing practitioner or his or her authorized agent directly or indirectly through one or more “contracted” parties to the pharmacy of the patient’s choice by electronic means including, but not limited to, telephone, fax machine, routers, computer, computer modem or any other electronic device or authorized means.

Question 4

Electronic signature

Answer 4

An electronic sound, symbol or process attached to or logically associated with a prescription record.

Question 5

Network vendor

Answer 5

Prescription transmission intermediary “contracted” by business associate agreements with appropriate parties involved, including point of care vendors, pharmacy computer vendors, pharmacies, to transmit the prescription information only having access to the prescription content to make format modification to facilitate secure and accurate data transmission in a format that can be received and deciphered by the pharmacy.

Question 6

Point of care vendor

Answer 6

An entity contracted with a prescriber to generate or transmit electronic prescriptions authorized by a practitioner directly to a pharmacy or to a “contracted” intermediary or “network vendor”, who will ultimately transmit the prescription order to a patient’s pharmacy of choice. Vendor must provide an unbiased listing of provider pharmacies and not use pop-ups or other paid advertisements to influence the prescriber’s choice of therapy or to interfere with patient’s freedom of choice of pharmacy. Presentation of drug formulary information, including preferred and non-preferred drugs and co-pay information if available, is allowed.

Question 7

Prescriber

Answer 7

A licensed practitioner who generates a prescription order and assumes responsibility for the content of the prescription.

Question 8

Remote pharmacist DUR site

Answer 8

A remote pharmacist practice site electronically linked to the New Mexico licensed pharmacy it operates through at which a pharmacist conducts drug utilization reviews. No dispensing will occur from a remote pharmacist DUR site.

Question 9

Advertising or to advertise

Answer 9

To inform customers by any means such as, but not limited to, shelf tags, preticketing, display card, handbills, billboards, and advertisements in the newspapers, magazines, the internet, radio and television or by mail

Question 10

Advertiser

Answer 10

Any person or firm which advertises dangerous drug prices or services, defined as the practice of pharmacy (Subsection BB of Section 61-11-2 NMSA 1978), to consumers in this state

Question 11

Article

Answer 11

Includes services as well

Question 12

Price disclosure

Answer 12

Is defined as in-store verbal disclosure of price, disclosure of prices by telephone, price lists, posters in-store containing retail prices for selected drugs indicating “our price”.

Question 13

Board

Answer 13

The New Mexico board of pharmacy.

Question 14

Nonresident pharmacy

Answer 14

Any pharmacy located outside New Mexico that ships, mails or delivers in any manner prescription drugs to New Mexico patients or consumers. For purposes of this definition only, “delivers” includes the provision of dispensing process pharmacy services such as prescription entry, prospective drug review, or prescription verification.

Question 15

Prescription drugs

Answer 15

Any drug required by federal or New Mexico law or regulation to be dispensed only by a prescription and includes “dangerous drugs” and “controlled substances” as defined by federal and New Mexico law.

Question 16

Resident state

Answer 16

The state in which the nonresident pharmacy is a resident.

Question 17

Centralized prescription dispensing

Answer 17

The dispensing or refilling of a prescription drug order by a retail or nonresident pharmacy.

Question 18

Dispensing

Answer 18

As defined in Paragraph (1) of Section 61-11-2, and pursuant to Subsection C of Section 61-11-21 NMSA 1978, dispensing is limited to a registered pharmacist.

Question 19

Automated drug distribution system or automated medication system

Answer 19

Or, “system” means a mechanical system that performs operations or activities, other than compounding or administration, related to the storage, packaging, or dispensing of drugs, and collects, controls, and maintains transaction information and records.

Question 20

Health care facility

Answer 20

A facility licensed under 16.19.11 NMAC or an inpatient hospice facility licensed under 16.19.10.12 NMAC.

Question 21

Managing pharmacy

Answer 21

An in-state retail pharmacy licensed by the board, pursuant to 16.19.6 NMAC that controls and is responsible for the operation of an automated drug distribution system.

Question 22

Multi-disciplinary committee

Answer 22

The pharmacist-in-charge, or the consultant pharmacist, and one or more representatives of the health care facility.

Question 23

Override medication

Answer 23

(a) a drug that may be removed from an automated medication system prior to pharmacist review because the multi-disciplinary committee has determined that the clinical status of the patient would be compromised by delay;
(b) a drug determined by the multi-disciplinary committee to have a low risk of drug allergy, drug interaction, dosing error, or adverse patient outcome, which may be removed from an automated medication system independent of a pharmacist’s review of the medication order or clinical status of the patient.

Question 24

Automated filling system

Answer 24

An automated system used by a pharmacy in the state of New Mexico to assist in filling a prescription drug order by selecting, labeling, filling, or sealing medication for dispensing. An “automated filling system” shall not include automated devices used solely to count medication that is then subject to final product check by a pharmacist prior to dispensing, vacuum tube drug delivery systems, or automated dispensing and storage systems used to dispense medication directly to a patient or to an authorized health care practitioner for immediate distribution or administration to the patient.

Question 25

Electronic verification system

Answer 25

An electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system that accurately verifies medication has been properly dispensed and labeled by, or loaded into, an automated filling system.

Question 26

Manufacturer unit of use package

Answer 26

A drug dispensed in the manufacturer’s original and sealed packaging, or in the original and sealed packaging of a repackager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label.

Question 27

Prepacked

Answer 27

Any drug that has been removed from the original packaging of the manufacturer or an FDA repackager and is placed in a properly labeled dispensing container by a pharmacy for use in an automated filling system for the purpose of dispensing to the ultimate user from the establishment in which the prepacking occurred.

Question 28

Repackager

Answer 28

Registered with the United States food and drug administration (FDA).

Question 29

Administer

Answer 29

The direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means as a result of an order of a licensed practitioner

Question 30

Board

Answer 30

The New Mexico Board of Pharmacy

Question 31

Distribute

Answer 31

The delivery of a drug or device other than by administering or dispensing

Question 32

Finished drug product

Answer 32

A form of the prescription drug which is, or is intended, to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling

Question 33

FD&C Act

Answer 33

The federal Food Drug and Cosmetic Act

Question 34

Repackaging

Answer 34

The act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug, excluding:

(a) placing medication in a different container to dispense directly to the patient pursuant to a patient-specific prescription;
(b) removing a drug product from the original container at the point of care for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient.

Question 35

USP

Answer 35

United States Pharmacopoeia

Question 36

USP standards

Answer 36

Standards published in the current official United States pharmacopoeia-national formulary.