Controlled Drugs for stock use must be ordered on a Controlled Drug Order book, with a separate page being taken for each order.  The entry must clearly detail:

• The name and location of the service and the date.
• Drug name, form, and strength and ampoule size if more than one available.
• Total quantity required in dosage units, e.g. number of tablets, ampoules or millilitres.
• The order must contain the signature and printed name of the Registered Nurse or suitably qualified Practitioner who is authorised by the Nurse in Charge of the department.

The receipt of Controlled Drugs must be checked against the amount ordered and the amount supplied by pharmacy to ensure that all amounts correlate.

The received order must be checked for any discrepancies (if a discrepancy is found it must be reported immediately to the specialist pharmacy technician in the supplying dispensary).

The receipt must be confirmed by the signature of the recipient on the controlled drug order book.

Details of the receipt of the CD must be entered into the main Controlled Drug Register in red ink prior to being distributed to GP bags:

• There must be a designated page for each medication, form and strength.
• Entries in the Controlled Drug register must be made in ballpoint pen.
• The serial number of the order, the date and the quantity received (in words) and the current balance must be entered and signed by the nurse and witness.
• The stock balance in the register must be checked against the stock in the Controlled Drug Cupboard.

Tamper-evident sealed packs/bottles need not be opened on receipt.  This leads to damage to the containers and increases the risk of breakage.  When sealed containers are opened for use this should be done in the presence of a witness where possible.  Any discrepancy must be reported to pharmacy.

Within the department, all CDs must be stored in a locked cupboard, which can only be opened by a person who can lawfully be in possession, such as the Registered Nurse in charge, a medical practitioner or a pharmacist.  General measures for the storage of CDs include the following:

• Cupboards must be kept locked when not in use.
• The lock must not be common to any other lock in the premises.
• Keys must only be available to authorised members of staff.
• No other medicines or items should normally be stored in the CD cupboard.
• CDs must be locked away when not in use.
• The Registered Nurse in charge is responsible for ensuring that the keys are kept secure when not in use.  This is particularly important outwith service opening hours.

Unpackaged ampoules should not be stored or transported and should always be contained within a well packaged box or container.

In all clinical locations where morphine injections are stored or administered a supply of naloxone 400micrograms in 1mL should be made available.

• Ask all staff on duty to check if they have the keys on their person.
• Contact staff who have left the premises.  If one of them has the key, they must return it immediately.
• Conduct a thorough search of the environment.
• If the key remains missing (either assumed lost or with a member of staff unable to return it) then the duplicate key may be issued for use.
• Carry out a full stock check.
• If the lock has to be replaced, ensure that the cupboard is not left unsupervised until that has been completed.
• Complete an electronic incident report recording all relevant details and actions taken.  All Incident Reports involving a CD must be tagged as a CD Incident on the Incident Reporting System to ensure that the report is automatically forwarded to the CD Accountable Officer Team.

• The drug name.

• The correct dose.  Where the prescribed dose is higher than the usual starting dose, check the patient's previous dose and formulation.  Where an increase in dose is intended, the prescribed dose should not usually be more than 50% higher than the patient's previous dose.

• Volume of bolus/infusion (additive, diluent/infusion).

• Route and rate of administration.

• Expiry date/time.

• Reconciling balance of stock against the Register balance after removing required quantity of drug.

Packaging is not discarded until the patient check has been completed.

The practitioner must check appropriate details of the patient.  Where possible, this should be independently*  checked (see below) by a second practitioner.  Checks relate to:

• The patient's name and date of birth corresponds with the details on the prescription.  Where this is not practical (e.g. patients with cognitive impairment), the patient may be identified via other means in accordance with local procedures.

• Confirm the patient is not allergic to the drug.

• The drug name.

• The dose administered is correct in relation to the prescription and is safe for the patient.

• The drug details on the original ampoule.

• Volume of bolus/infusion.

• Route and rate of administration.

• Expiry date/time.

*independently is defined as an individual undertaking the above process on their own without verbal or other communication during the checking process.

This is a two step process, step one is the check when opening the controlled drug receptacle, step two is the check on administration to the patient.

The CD Register in the GP home visit bag should be completed with the following details:

• Date and time when dose administered.

• Name of patient.

• Quantity administered.

• Form (name, formulation and strength) administered.

• Name/signature and printed name of practitioner administering the dose

• Name/signature and printed name of witness to the administration, where applicable.

• Balance in stock

• An appropriate record of administration must also be entered on the electronic patient record.

Where only part of an ampoule containing a CD is used, the unused quantity should be disposed of down a sink on the premises and the amount of medication administered and the amount discarded must be recorded.  This should be witnessed where possible by a second practitioner who should also sign the record. 

CONFIRM that administration has been recorded on the electronic patient record.

Discrepancies

In the event of a discrepancy in stock levels, this must be recorded in the same manner and then once the stock levels are reconciled the details must be entered of where the discrepancy was found.  This completes the audit trail.  It is not appropriate, or considered best practice to find a discrepancy and leave the recording sheet blank, but to document this accurately.

In the event of a discrepancy of a controlled drug stock balance, or in the loss of Controlled Drugs, the matter must be investigated immediately by the Registered Nurse in charge.

• The investigation must include a stock check of all Controlled Drugs, the record books from the cupboard and bags in the unit, and order book against all controlled drugs received and administered since the previous check found to be correct.  At this point also ensure controlled drug book correlates with GP bag and the levels are not being checked against the wrong register.

• Check books for discrepancies in entering details, miscalculations of remaining stock or any numeric errors.

• Ensure that controlled drug box/ampoule has not been inadvertently placed within another container in the bag/cupboard.

• Consider when the drug may have been given, and by whom.  If missing from GPs bag, then clarify where possible which GP used the particular bag and which visits the GP undertook.

• Consider review of drivers log sheet, which may indicate patients visited during the timescale and should also indicate which GP carried out the home visit.

• Consider review of electronic records of patients seen where a controlled drug may have been prescribed and administered.  This may be done by electronic search, by either entering the drug name as search, or by entering the clinician's name as search between specified dates.

• If no entries are found electronically and the drug name has not been added to electronic record, then a Datix report requires to be completed as this is in clear breach of standards for recording the administration of Controlled Drugs.  The report must be tagged as a CD Incident to ensure that it is automatically forwarded to the CD Accountable Officer.

• If none of the above steps result in reconciliation of stock report immediately to the Lead Nurse of their deputy.

If the error or omission is traced, the Registered Nurse in Charge must make an entry in the CD register clearly stating the reason for the entry and the corrected balance.  This entry must be witnessed by another healthcare professional and both must sign the CD register.

If the discrepancy cannot be resolved, the Registered Nurse in Charge must make an entry in the CD register clearly documenting the discrepancy, (including the actual balance) and stating that this is under investigation.  The entry must be witnessed by another healthcare professional and both must sign the CD register.  The line/duty manager and pharmacist must be notified (within working hours) and the discrepancy handled in accordance with Section 8.5.

A check of all CDs stocked within wards and department must be completed every 3 months by Pharmacy (either a pharmacist of pharmacy technician).  See Appendix 8.

Used medicated patches may still contain a small quantity of active drug and should therefore be folded in half and disposed of in a pharmaceutical waste bin (generally blue lidded).

Out of hours policy is not to accept patient-returned CDs. In exceptional circumstances where this is necessary and direct return to a community pharmacy on behalf of the patient is not possible.  They should be placed in the CD cupboard, clearly marked and segregated from stock.  The following details should be recorded in the back page(s) of the CD register:

• Date.
• Name, form and strength and quantity of CDs.
• Name and address of person from whom CDs received.
• Patient's identity (if different from above).
• Signature of person acknowledging acceptance of the CDs.
• Signature of person witnessing same (this could be the person from whom received).

Arrangements should be made for a pharmacy staff member to visit to destroy these CDs.

Stock Controlled Drugs which have expired or are no longer required must not be returned to pharmacy.  They should be clearly marked and segregated within the CD cupboard so they are not used for patients then destroyed in the department in the presence of a pharmacist or pharmacy technician.  For further information refer to Section 8.8.