247 CMR: Board of Registration in Pharmacy

6.12: Deficiency Statements

After every Board inspection in which any violation of 247 CMR 2.00 et seq. is observed, the Board or its designees shall prepare a deficiency statement citing every violation observed, a copy of which shall be sent to the pharmacy or pharmacy department.

6.13: Plans of Correction

A pharmacy or pharmacy department shall submit to the Board a written plan of correction of violations cited in a deficiency statement prepared pursuant to 247 CMR 6.12 within 15 business days after the deficiency statement is sent. Every plan of correction shall set forth, with respect to each deficiency, the specific corrective step(s) to be taken, a timetable for such steps, and the date by which compliance with the relevant 247 CMR section will be achieved. The timetable and the compliance dates shall be consistent with achievement of compliance in the most expeditious manner possible. A plan of correction which does not meet the requirements of the relevant 247 CMR section shall be considered unacceptable by the Board and returned to the pharmacy or pharmacy department.

6.14: Duty to Report Certain Improper Drug Dispensing to the Board

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 the definition of Quality‑related Event or QRE appearing in 247 CMR 15.01.

(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.

REGULATORY AUTHORITY

247 CMR 6.00: M.G.L. c. 112, §§ 42A and 30; c. 138, §§ 29 through 30G.

Documents


This information is provided by the Division of Health Professions Licensure within the Department of Public Health.