TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING

CHAPTER 19 PHARMACISTS

PART 25 ADVERSE DRUG EVENT

16.19.25.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy, Albuquerque, NM, (505) 841-9102.

[16.19.25.1 NMAC - N, 03-30-02]

16.19.25.2 SCOPE: All persons or entities that dispense, administer, deliver or conduct research using dangerous drugs.

[16.19.25.2 NMAC - N, 03-30-02]

16.19.25.3 STATUTORY AUTHORITY: Section 61-11-2 DD defines significant adverse drug event. Section 61-11-18.1 NMSA 1978 authorizes the Board of pharmacy to promulgate regulations regarding the prevention and reporting of significant adverse drug events.

[16.19.25.3 NMAC - N, 03-30-02]

16.19.25.4 DURATION: Permanent.

[16.19.25.4 NMAC - N, 03-30-02]

16.19.25.5 EFFECTIVE DATE: March 30, 2002, unless a later date is cited in the history note at the end of a section.

[16.19.25.5 NMAC - N, 03-30-02]

16.19.25.6 OBJECTIVE: The objective of Part 25 of Chapter 19 is to protect the health and welfare of the citizens of the State of New Mexico against significant adverse drug events.

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16.19.25.7 DEFINITIONS:

A. "Significant Adverse Drug Event" means a drug related incident that results in harm to the patient.

B. "Incident" means a drug that is dispensed in error, that is administered and results in harm, injury or death.

C. "Dispensing Error" means a prescription that was dispensed from the pharmacy differently from what was prescribed.

D. "Harm" means temporary or permanent impairment of the physical, emotional or psychological function or structure of the body and/or pain resulting there from requiring intervention.

[16.19.25.7 NMAC - N, 03-30-02]

16.19.25.8 THE PHARMACIST IN CHARGE SHALL:

A. Develop and implement written error prevention procedures as part of the Policy and Procedures Manual.

B. Report incidents, including relevant status updates, to the Board on Board approved forms within fifteen (15) days of discovery.

[16.19.25.8 NMAC - N, 03-30-02]

16.19.25.9 THE BOARD SHALL:

A. Maintain confidentiality of information relating to the reporter and the patient identifiers.

B. Compile and publish, in the newsletter and on the Board web site, report information and prevention recommendations.

C. Assure reports are used in a constructive and non-punitive manner.

[16.19.25.9 NMAC - N, 03-30-02]

History of 16.19.25 NMAC: [RESERVED]