Controlled drugs

15.1    The Misuse of Drugs Act 1971 places controls on certain prescribed medications (known as controlled drugs) because of their potential for misuse. The Misuse of Drugs Regulations 2001 categorises controlled drugs into five schedules. Different legal requirements for how controlled drugs must be stored and for record keeping apply to each schedule. To meet our legal obligations, we must:

• securely store all controlled drugs in Schedule 2 and certain controlled drugs in Schedule 3 as set out in paragraphs 15.7 – 15.10
• record the receipt, administration and disposal of Schedule 2 controlled drugs in the controlled drugs register in addition to all other records required by this policy and local procedures

15.2    This section sets out the council’s requirements for all medication in Schedule 2 and medication in schedule 3 to which legal requirements apply.

 Identifying controlled drugs when they are received

15.3    Staff who receive medications from any source are responsible for checking whether or not the medication is a controlled drug.  Any community pharmacy will be able to help identify controlled drugs and advise about storage and recording requirements. Reliable online information can be found at Online BNF (Adults); Online BNF for Children;  GOV.UK common controlled drugs list; CQC guidance   (controlled drugs in care homes). 

15.4    When a medication is identified as a controlled drug, staff must:

• check which schedule applies to the medication
• record the receipt of medications in Schedule 2 in the controlled drugs register 
• ensure that medication in schedule 2 and medication in schedule 3 to which legal requirements apply are stored as set out in paragraphs 15.7 – 15.10

Double staff involvement – controlled drugs register and the MAR

15.5    Two staff must be involved in updating the controlled drugs register and the MAR whenever Schedule 2 controlled drugs are received, administered, disposed of and stock balances checked.

15.6    One staff member must carry out and record the activity then sign and date the record. The second staff member must check that everything is correct and countersign the record.

Storage requirements for controlled drugs 

15.7    Access to controlled drug storage areas will be restricted according to need.  Risk assessments will be used to decide who may hold keys.

15.8    Adult services must store all schedule 2 controlled drugs and those schedule 3 controlled drugs to which secure storage requirements apply:

• in a dedicated controlled drugs cupboard which meets the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973 (safe custody regulation), or
• in a separate container in a safe which complies with the safe custody regulation, or 
• in a locked box separate from other medications in a standard locked medicines refrigerator if the medication requires refrigeration

15.9    Children’s homes are not subject to the safe custody regulation. Controlled drugs will be stored in a locked internal cabinet in a locked medication cabinet secured to the wall within a locked medication room or in a locked container in a refrigerator within a locked room if the medication requires refrigeration.  

People who manage their own medication:

15.10    People who are using controlled drugs and manage their own medication are not subject to the safe custody regulation. Decisions about safe storage of controlled drugs managed by someone using the service will be based on risk assessment and recorded on the person’s plan. The storage place must not be accessible to other people. This could be a lockable cupboard or drawer in their room.

Missing stock

15.11    Services must report missing stocks of controlled drugs that cannot be accounted for to the regional Controlled Drugs Accountable Officer (CDAO) at NHS England. 

15.12 If the incident meets the criteria for statutory notification, regulated adult services must also report the incident to the Care Quality Commission (CQC).