Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department
Section 6.14 - Duty to Report Certain Improper Drug Dispensing to the Board

Universal Citation: 247 MA Code of Regs 247.6

Current through Register 1531, September 27, 2024

Effective January 1, 2010, a pharmacy licensed by the Board is required to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, as defined by the Board, as soon as is reasonably and practicably possible but not later than 15 business days after discovery or being informed of such improper dispensing. The duty to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, pursuant to M.G.L. c. 112, § 39D and 247 CMR 6.14(2), shall be in addition to the Continuous Quality Improvement (CQI) Program requirements of 247 CMR 15.00. Only those events of improper dispensing of a prescription drug that result in serious injury or death are required to be reported to the Board, in accordance with M.G.L. c. 112, § 39D and 247 CMR 6.14(2).

(1) Definitions. For purposes of reporting to the Board, as required by M.G.L. c. 112, § 39D:

(a) Improper Dispensing of a Prescription Drug shall mean the incorrect dispensing of a prescribed medication that is received by a patient, as more particularly described in 247 CMR 15.01: Quality-related Event or QRE.

(b) Pharmacy, as referenced in 247 CMR 6.14, shall mean a pharmacy, or a group of pharmacies under common ownership and control of one entity, licensed by the Board pursuant to M.G.L. c. 112.

(c) Serious Injury shall mean an injury that is life threatening, results in serious disability or death, or requires a patient to undergo significant additional treatment measures.

(d) Serious Disability shall include, but is not limited to, injuries requiring major intervention and loss, or substantial limitation, of bodily function lasting greater than seven days (e.g. bodily function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and out of bed, chair, etc.; hearing; seeing; sitting; sleeping or walking).

(2) Reporting Responsibility. Effective January 1, 2010, a pharmacy shall file a report with the Board of the improper dispensing of a prescription drug that results in serious injury or death, on a form to be provided by the Board, within 15 business days of the pharmacy discovering or being informed of such improper dispensing. A pharmacy shall provide all records relating to such improper dispensing to the Board upon request.

(3) Records Retention. The pharmacy shall retain all records relating to the improper dispensing of a prescription drug that results in serious injury or death which is required to be reported to the Board, in accordance with the requirements of M.G.L. c. 112, § 39D and 247 CMR 6.14(2), for a minimum period of two years from the date the report is filed with the Board.

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