Circular Letter 6-97-365
|TO:||All Licensed Health Care Facilities|
|FROM:||Paul Dreyer, Ph.D., Director, Division of Health Care Quality|
Grant Carrow, Ph.D. Director, Drug Control Program
|DATE:||June 9, 1997|
|RE:||Requirements for Reporting of Thefts or Loss of Controlled Substances|
The purpose of this memorandum is to review current requirements for reporting the theft or loss of controlled substances by all licensed health care facilities. Regulations of the Department of Public Health at 105 CMR 700.005(A) require every licensed health care facility to report the theft or loss of a controlled substances to the Drug Control Program (DCP) immediately upon discovery by telephone, followed up in writing within 7 days of the incident.
In January this year, the Department modified its requirements for reporting the theft or loss of controlled substances by licensed health care facilities. Facilities licensed by the Division of Health Care Quality (DHCQ) that possess controlled substances will no longer be required to notify the DHCQ in addition to the Drug Control Program of incidences of theft or loss of controlled substances.
Instead, the DCP, which is the primary agency within the Department charged with investigating cases involving the theft or loss of controlled substances, will notify DHCQ of these reports. Licensees are still mandated to contact DHCQ to report other types of reportable incidents occurring within the facility. (e.g. patient harm).
The Department considers the loss of one unit of medication to be significant enough to warrant a report of such loss since such thefts or losses may be part of a pattern within a facility or among several area institutions. In addition, regulations of the Board of Registration in Pharmacy at 247 CMR 6.02(10) require its registrants to report such losses to the board within 7 days using a DEA Form 106. Federal reporting requirements for Schedule II-V controlled substances may differ. Please consult with the Boston Field Office of the Drug Enforcement Administration at (617) 557-2100 for further guidelines on reporting thefts or loss of controlled substances to federal agencies.
Please note that a DEA Form 106 is not necessary in a long term care setting, however the loss must be reported to the Department. Depending on the severity of the cases, facilities may also want to contact the Massachusetts State Police Diversion Investigative Unit at (617) 727-2117 or their local police department.
For further information or to report a drug loss to the Drug Control Program, call (617) 983-6700. To report other types of reportable incidents contact the Division of Health Care Quality's Complaint Unit at (617) 753-8150.
This information is provided by the Drug Control Program within the Department of Public Health.