General
Regulations of the Department of Public Health at 105 CMR 700.005 require every registrant to provide effective physical security controls against theft and diversion of controlled substances. Access to all controlled substances must be restricted to authorized personnel. In order to reduce the likelihood of diversion and enable timely identification of potential problems, hospitals and clinics must maintain strict accountability of controlled substances in Schedules II-V and an effective level of accountability for those controlled substances in Schedule VI. All controlled substances must be dispensed pursuant to a legal prescription or medication order.
Pharmacy Department
Schedule II Controlled Substances
- All controlled substances in Schedule II must be stored in a vault or its equivalent. Inventory may be tracked via computer, however a perpetual inventory of all Schedule II controlled substances must be maintained on hard copy
- Only licensed pharmacists should have access to Schedule II drugs
- Access to the vault should be restricted to a licensed pharmacist
Schedule III-IV Controlled Substances
- Hospital pharmacies and clinics with pharmacies are not permitted to commingle Schedule III-IV drugs within the pharmacy or bulk picking "bins"
- All bulk Schedule III-IV controlled substances must be stored in such a manner as to restrict access to only licensed pharmacists and must be maintained with perpetual inventory
- An accountability system must be maintained that would deter and detect diversion
Schedule V Controlled Substances
- Hospital pharmacies and clinics with pharmacies must maintain accountability for these drugs;
- Access to all bulk Schedule V controlled substances should be limited to authorized pharmacy personnel unless packaged in tamper resistant (i.e. unit dose) form
Schedule VI Controlled Substances
- Schedule VI controlled substances must be dispensed pursuant to a legal prescription or medication order
- An accountability system must be maintained that would deter and detect diversion
Nursing Units
General
- Access to all controlled substances must be limited to licensed, authorized staff
- All controlled substances in Schedules II-VI must be packaged in tamper-resistant packaging
- A quality assurance review of all controlled substances administered must be conducted and documented by nursing/pharmacy management not less than once per week
- All refrigerated controlled substances must be double locked and maintained in a dedicated medication refrigerator accesible only by licensed staff
Schedule II-V Controlled Substances
- All controlled substances in Schedules II-V must be maintained in a double-locked, permanently affixed cabinet or medication cart with either hardcopy or electronic perpetual inventory
- All disposal of unused portions of Schedule II-V controlled substances must be conducted by two licensed staff and co-signed with the appropriate documentation unless the policy of the hospital/clinic is more restrictive
Schedule VI Controlled Substances
- Controlled substances in Schedule VI must be maintained in a locked medication room or closet
- All disposal of unused portions of Schedule VI controlled substances must be conducted by a registered nurse unless the policy of the hospital/clinic is more restrictive
Thefts or losses
All thefts or loss of controlled substances, whether confirmed or suspected, must be reported immediately upon discovery to the Department's Drug Control Program, pursuant to 105 CMR 700.005 and written policies of the Department.