Controlled Drugs (CDs) Policy

What are controlled drugs?

A controlled drug is a prescription-only medicine which is subject to extra controls under the Misuse of Drugs legislation. Common examples include morphine, fentanyl, buprenorphine, temazepam, and midazolam.

Stricter legal controls apply to controlled drugs to prevent them from being misused, obtained illegally, or causing harm. These controls govern how they are produced, stored, supplied, and prescribed. By law, controlled drugs are classified into five schedules based on their benefit when used in medical treatment and the likely harm if misused. Schedule 1 has the highest level of control, although these drugs are rarely used as medicines; schedule 5 has the lowest level of control. Drugs in schedule 2 & 3 are those which are likely to require special arrangements in care homes.

Examples of CDs used in care facilities and the wider community setting:

Schedule 1: Includes drugs that are primarily not used medicinally such as cannabis and LSD. A special Home Office Licence is needed in order to possess these.
Schedule 2: Includes drugs such as diamorphine, morphine, pethidine, cocaine, which are subject to full CD requirements relating to prescriptions, storage, and records. In residential or nursing homes they must be stored in a special cupboard and a register of the use of these drugs must be kept in addition to the administration records on the Medication Administration Record (MAR) sheet.
Schedule 3: Includes most barbiturates and buprenorphine. These drugs are subject to the special requirements for prescriptions, but records do not need to be kept in a register, and they do not need to be stored in a CD cupboard. Buprenorphine and Temazepam are an exception as they must be stored in a CD cupboard and good practice to enter in CD register. Tramadol, Gabapentin, and Pregabalin are also Schedule 3s; they do not need to be in CD cupboard or CD register; however, good practice.
Schedule 4: Benzodiazepines and anabolic steroids. There are no special requirements for writing prescriptions, records do not need to be kept, and they do not need to be stored in a CD cupboard. Schedule 4 exists mainly to exert control on the destruction of these drugs by importers, exporters, and manufacturers. A Home Office licence is also required to import/export anabolic steroids. Also includes Diazepam, Sativex Mouth Spray (cannabis) used for MS, no CD cupboard or CD register required.
Schedule 5: Includes those preparations which are exempt from virtually all CD requirements because they are dilute and therefore not as liable to abuse e.g., Oramorph 10mg/5ml solution. There are no special requirements for writing prescriptions, additional records do not need to be kept, and they do not need to be stored in a CD cupboard, although everyone treats this is as a CD (good practice). However, note that Oramorph Concentrate 100mg/5ml is a schedule 2 and must legally be kept in a CD cupboard.

All regulated residential care facilities should have access to the British National Formulary (BNF). This can be hardcopy or electronic format. These are issued in March and September of each year. It is good practice to renew copies on an annual basis to ensure up-to-date and accurate information is to hand.

Care Quality Commision CQC requires Providers to have:

Systems in place to reflect on the findings of their service reviews and as it does so, learns from adverse events, incidents, errors, and near misses relating to medicines that have occurred within the service and elsewhere so that the risk of them being repeated is reduced to a minimum.
Systems in place to ensure they comply with the requirements of the Medicines Act 1968 and the Misuse of Drugs Act 1971, and their associated regulations, the Safer Management of Controlled Drugs Regulations 2006, relevant health technical memoranda and professional guidance from the Royal Pharmaceutical Society of Great Britain and other relevant professional bodies and agencies.

Overall, the CQC expects providers to have robust systems in place to manage and administer controlled drugs safely and effectively, as part of their overall approach to managing medicines in a care setting.

Supplies of Controlled Drugs

Supplies will usually be on NHS prescriptions, which are only valid for 28 days from the date they are signed.
Doctors and dentists can prescribe all controlled medicines to treat illness or injury. Other healthcare professionals, including nurses and pharmacists who have received additional training may prescribe controlled medicines.
Care staff collecting a prescription for a schedule 2 or 3 controlled drug from the pharmacy or GP dispensary will be asked to sign a specific box on the back of the prescription to confirm that they have received the drug.
In addition, for schedule 2, staff will be asked for proof of identity, which could be a driving licence or passport.

Storage of CDs

The controlled drugs cupboard must meet British Standard BS2881:1989 security level 1. The Safe Custody Regulations specify the quality, construction, method of fixing, and lock and key for the cupboard.
The controlled drugs cupboard must be:
- secured to a wall and fixed with bolts that are not accessible from outside the cupboard
- fitted with a robust lock
- made of metal with strong hinges. The walls of the room must be of a suitable thickness and made of a suitable material, for example bricks. This means that the cupboard must be securely fixed to a wall.
- Personal items belonging to either staff or Services Users must not be stored in a CD cupboard.
Where a safe is used for storing CDs, a separate container must also be used.
For each Service User who is prescribed CDs they must be stored separately and not ‘mixed’ with other Service Users’ CDs to minimise the risk of error.

Recording of controlled drugs

A separate record must be kept of the receipt, administration and disposal of CDs.
These records must be kept in a bound book with numbered pages (CD Register).
There must be a separate page for each CD for each person, with the name, dose and strength of the drug written clearly at the top of each page.
All entries in the register must be signed and witnessed by a second authorised member of staff.
When a drug is received, the date, quantity and where it came from must be entered into the register, the running balance calculated, signed by the staff member receiving the drug, and witnessed by a second authorised member of staff.
Administration must be recorded both on the MAR and in the CD record book.
Record the time and dose given. Check and record the balance remaining. Ensure person administering the drug and authorised witness both sign the entry.
Do not cross out any errors in the CD register. Errors must be marked as “entered in error” signed, witnessed and dated. The correct entry must then be made using a new line.
Checks must be made on the amount in the pack or bottle at each administration and also on a regular basis, e.g. at handover of each shift.

Administration of CDs

When administering a CD you must follow all the steps involved in giving any other medicine. Records must be made in the CD register as described above in addition to the normal record on the MAR chart. The administration of CDs is a two-person process, both members of staff must be trained in accordance with company policy to ensure the process is suitably robust and risks of errors minimised, as far as reasonably practicable.

A Controlled Drugs register, which must be a bound book, will be provided and reserved solely for the purpose of recording, receipt and administration of controlled drugs.
All entries must be in indelible black ink.
A separate page must be used for each type/form/strength of medicine.
A separate page must be used for each Service User.
Entries must be in chronological sequence. Entries must be made at the time of transaction.
Corrections must be dated, signed and made in such a way as to ensure that the original entry can still be read.
Receipt of controlled drugs will be recorded at the time of their arrival at the facility and be checked and signed for by 2 people both of whom must be within the competency framework time scales.
Quantities received must be entered in the register at the appropriate point and a running total of the quantity of medicine in stock must be maintained.
Controlled drugs must be administered by a designated Senior Carer, who holds the controlled drug key separately from all others.
Controlled drugs must be checked by a second person prior to administration. The checking includes observing the medicine being dispensed, checking the name of the recipient, ensuring the right dose, route, strength has been dispensed and witnessing of the Service User taking the medicine correctly. The second person must be in attendance for the whole administration process. At no time should there be a delay in dispensing/administering and/or signing of the CD.
Quantities of controlled drugs at the facility will be checked on a weekly basis by a member of the management team.
The controlled drugs register will be signed and dated to confirm that the check has taken place.
If an error occurs within any part of the CD policy, during a compliance visit from CQC/Commissioning team or noted through an internal audit process, the management team is required to be notified, without delay.
Controlled Drug registers must be kept for 3 years from date of last entry.
Controlled drugs may only be held as prescribed and supplied for individual named Service Users.
Controlled drugs must be disposed of as soon as practicable when the expiry date is reached, when treatment is discontinued or when an individual Service User dies.
Controlled drugs must be retained for seven days after the death of the Service User for whom they were prescribed.

Procedure for Administration of Controlled Drugs

The following procedure must be undertaken by two staff. One member of staff will be responsible for the administration of the medication; the second member of staff will be responsible for witnessing the entire process.

Hands must be washed using liquid soap and water and thoroughly dried.
Before administering any prescribed medication check the identity of the Service User.
Check that the prescribed medication is due and has not been given already.
Check that the information contained in the Controlled Drugs register and the MAR sheet is complete, correct and clearly written.
Select the required medication.
Check the details on the label are the same as those on the MAR sheet.
Check the expiry date (where applicable).
Check the dose of the medication.
Empty the required medication into an appropriate container – avoid touching the medication.
Take the medication to the Service User for whom it has been prescribed.
Provide, where appropriate, the Service User with a drink with which to take the prescribed medication. Alternatively, refer to the Covert Medicines policy, as required
Observe the Service User to ensure that the prescribed medication is taken in the way in which it has been prescribed. (This must be orally or through adhesive patches to the skin).
When the prescribed medication has been taken by the Service User the Controlled Drug register and MAR sheet must be signed using black, indelible ink, by both members of staff.
If the Service User refuses the medication, the appropriate code must be used on the MAR sheet and the reason for the refusal recorded in the care records. This must be signed by both members of staff.
Additionally, the Controlled Drug register will also need to reflect the refusal of medication by the Service User. This will be indicated in the running total of the remaining drugs and the reason for the refusal noted. This must be signed by both members of staff.
Once the medication has been administered any used medication pots must be collected, washed and dried for future use.
The Controlled drug register must be returned to the controlled drugs cabinet and locked.

Destruction of controlled drugs

In care settings that are not registered to provide Nursing care, CDs must be returned to the pharmacist or dispensing doctor who supplied them for safe denaturing and disposal.
A record of the return must be made in the CD register.
It is good practice to obtain a signature for receipt from the pharmacist or dispensing doctor

Investigating / reporting of incidents involving controlled drugs

Any queries/concerns regarding the management of medication must be directed to the management team, in the first instance.
Incidents involving CDs must be reported to CQC, by an appropriately authorised person in accordance with CQC policy procedure however, this does not prevent any person using the whistleblowing procedure to highlight and concerns an employee/relative and/or a Service User may have. CQC and the Local Safeguarding team offers a confidential service for reporting accidents/incidents/concerns any person may have.
Anyone who wilfully misuses a Service User’s medication will be subject to investigation and appropriate actions which, may include disciplinary action and subsequent dismissal due to the serious nature a mistake in administration may have.