Section 20.02 - Duty to Report Certain Improper Drug Dispensing and Serious Adverse Drug Events to the Board(1) A Manager of Record of a pharmacy shall report to the Board any improper dispensing of a prescription drug that results in serious injury or death within seven business days of discovery of serious injury or death related to improper dispensing.(2) A Manager of Record of a pharmacy, shall report any serious adverse drug event that occurs as a result of a patient's interaction with any drug or pharmaceutical manufactured, produced, or compounded at the pharmacy, to: (b) the Federal Food and Drug Administration MedWatch Program; and(c) the Betsy Lehman Center for Patient Safety and Medical Error Reduction. A Manager of Record shall report a serious adverse drug event within seven business days of the knowledge of the serious adverse drug event by any pharmacy employee.
(3) The duty to report to the Board improper dispensing of a prescription drug that results in serious injury or death or a serious adverse drug event shall be in addition to the Continuous Quality Improvement (CQI) Program requirements of 247 CMR 15.00: Continuous Quality Improvement Program.(4) A pharmacy shall retain all records relating to the improper dispensing of a prescription drug that results in serious injury or death and all records relating to serious adverse drug events for a minimum period of five years from the date the report is filed with the Board. The records shall be readily retrievable.(5) The reporting requirements in 247 CMR 20.02 do not apply to non-resident pharmacies.Adopted by Mass Register Issue 1536, eff. 12/6/2024.