SAFE AND SECURE HANDLING OF MEDICINES

Section 8.5. Controlled Drug Stock

8.5.1. Controlled Drug Stock

The Ward/Department should have a list of the CDs to be held in each Ward/Department as stock items, including minimum stock levels. The contents of the list must reflect current patterns of usage of CDs in the Ward/Department and must be agreed between the Pharmacist or Pharmacy Technician responsible for stock control of medicines and the Senior Charge Nurse/Midwife.

The list must be modified if practices change and must be subject to annual review.

Where possible, routine orders should be placed on Monday - Friday and not on weekends/public holidays.

 

8.5.2. Daily Controlled Drugs Stock Check

The Senior Charge Nurse / Midwife / Operating Department Practitioner is responsible for ensuring that daily stock checks are performed once every 24 hours. The stock balance of CDs, (tablets, capsules, injections and patches) must be physically counted by two registered members of staff. If this cannot be done, complete a DATIX report. Patient’s Own CDs must be checked and signed for during the daily stock check.

The CD check must be carried out by two registered healthcare professionals or one registered nurse and one student nurse / midwife.

 

Student nurses / midwives can be involved in this process once they have successfully completed the administration of medicines theory and simulated practice within their educational programme.  

 

It is good practice to rotate the staff undertaking the CD checks.

 

Expiry dates of stock should also be checked on a regular basis.

 

 

 

8.5.3. Procedure for Daily CD Stock Checking

Checking of CD stocks must include:

·         Checking the running balance in the CD Register against the contents of the CD Cabinet, not the reverse, to ensure that all balances are checked.

·         Ward staff carrying out their daily check should physically check the balance of all CDs, for example, tablets, capsules, injections and patches against that documented in the CD Register to ensure they are the same but do not write anything in the Register. 

·         The best time for performing the Daily CD Stock Check is at handover between dayshift and nightshift.

·         The two members of staff then sign the daily check sheet to confirm that they have carried out the check once finished checking the contents of the cupboard

·         It is not necessary to open packs with tamper evident seals but the integrity of all packaging and products must be assessed.

·         Oral liquid preparations of CDs should not be physically measured at every CD check. Instead, a visual estimation approach is an acceptable method. If a discrepancy is suspected a registered healthcare professional may undertake a physical measurement of open bottles of liquid CDs. Routine periodic volume measurement checks should be implemented by Senior Charge Nurse / Midwife / Operating Department Practitioner to ensure volumes recorded in the CD Register are accurate and reflect actual stock balance. (It should be assumed that manufacturer sealed bottles contain the amount stated on the label). Plastic cups are not appropriate for accurately measuring CDs. (Contact pharmacy if advice is required on measuring CD liquids accurately) (see Section 8.5.5.).

·         The balance for liquids must be confirmed on completion of a bottle. The balance should be adjusted / agreed once a bottle has been finished. Bottles which contain a shortened expiry date once opened must be physically measured if the expiry date has passed before completion of the bottle.

·         A record of any reconciliation must be made in the CD Register.

·         Expiry dates must be checked.

·         If patient’s own CDs are stored then these must also be checked.

·         Ensure that there is adequate stock and re-order if required.

A record of all CD stock checks must be made in the appropriate documentation.

 

If an error or omission can be explained the registered healthcare professional must make an entry in the CD Register clearly stating the reason for the entry and the correct balance. This entry must also be witnessed and signed by a second registered member of staff. An unexplained discrepancy must be reported immediately to the Senior Charge Nurse or Midwife in charge. A DATIX must then be logged following this verbal communication.

Never leave an unlocked CD Cabinet unattended at any time.

 

 

8.5.4. Four Monthly CD Audit by Pharmacy Staff

 

A check of all CDs stocked within Wards / Departments must be completed every four months by a member of Pharmacy (Pharmacist / Pharmacy Technician) and a registered Nurse.

 

Wards/Departments may request additional CD stock checks if issues are identified or suspicions arise.

 

These checks must take place in accordance with Pharmacy SOPs. 

 

Stock checks must be clearly made in the CD Register using red ink.

 

The entry must be signed and dated by a Pharmacist / Pharmacy Technician.

 

See link to Controlled Drugs Check Report.

 

8.5.5. Measuring CD Liquids

The Pharmacist / Pharmacy Technician performing the stock check with the registered member of staff (Nurse) must check the volume of all liquid CDs. These must be checked visually and only measured using an appropriate calibrated measure. Plastic medicine cups are not suitable for accurately measuring CDs.

When measuring liquid CDs, ensure:

·         Place the measuring cylinder on a flat, hard surface

·         Eye line is at the same height as the bottom of the meniscus

·         Bottom of the meniscus is the accurate measurement

CD Liquids Pic 1                              CD Liquids Pic 2

If the stock level has not been rebalanced by staff every time they open a new bottle, even if the volume appears visually accurate, you must measure all opened bottles using an appropriate calibrated measure and annotate the actual stock balance in the appropriate CD Register.

Section 8.5.5. Example Form

Measuring Liquid CD Dose for Administration to Patient:

·         Use an oral dose 5mL syringe to measure the required dose

·         Always use the syringe with the bottle adaptor described above

·         Allow the patient to take the dose directly from the syringe or put the measured dose in a medicine cup to administer to the patient

·         Double rinse out the medicine cup and oral syringe with water

·         Dispose of medicine cup and syringe in general waste

 

8.5.6. Minimise Loss of Liquid CDs

To reduce / minimise loss of liquid CDs when measuring doses for administration to patients, it is advised that an adaptor is used for each bottle of liquid CDs as follows:

·         Insert Baxter Healthcare Bottle Adaptor into the top of the bottle of liquid CD

·         Keep this bung in situ until the bottle is empty or the contents have expired

·         Replace the cap on bottle each time it is used

·         Double rinse the bung and cap then dispose of in general waste stream once no longer required

A liquid discrepancy is defined as +/-5% of the volume contained in the bottle.

Section 8.5.6. Example Form

8.5.7. Liquid CD Spillages

When spillages occur, a witness is required to verify that the spillage has occurred and this should be recorded in the CD Register (as process for breakages/spillages/dropped doses section - see Section 8.8.8.) and signed by both the person making the spillage and the witness. To accurately record the volume lost, the remaining volume in the bottle should be measured and the total balance should reflect what volume remains. A DATIX must be submitted following any loss or breakage of CDs.

For large liquid CD spillages, for example, Methadone, use paper towels to soak up the liquid from the surface. The used paper towels should then be placed into a blue lidded pharmaceutical waste container and Vernagel placed over the used paper towels. The used paper towels must not be disposed of in normal waste streams or rinsed down the sink.

In place of residence, for example, patients own home, nursing home, care home, group home, this person may be a Health Care Support Worker, relative, carer or the patient.

Section 8.5.7. Example Form

8.5.8. Controlled Drug Discrepancies

The balances in the CD Register must always tally with the amounts of CDs in stock.  If they do not, the discrepancy must be fully investigated as soon as possible (see Section 8.7.2.).  In the first instance the following should be carefully checked:

·         Arithmetic since last correct balance.

·         Re-check CD Cabinet or GP bag with second person (remember to include date expired stock and exclude patient returns which may have become mixed with stock).

·         Other CD Register sections of same drug class for erroneous entries.

·         Other holdings, for example, GP bags for stock which may have been transferred but not recorded.

·         Sense-check register (correct pack sizes, patterns of entry for potential missing entries, and unusual quantities).

·         All orders have been entered into the CD Register by checking CD Register and CD Order Book on the Ward / Department as well as delivery notes / invoices / stock orders within Pharmacy for discrepancies.

·         All CDs administered have been entered into the CD Register. This would involve checking every patient’s TPAR.

·         Check diary and contact all relevant practitioners who have worked at the Ward / Department during the relevant period to verify any supplies made that may have not been entered or been entered erroneously.

If the error or omission is traced, Senior Charge Nurse / Midwife / Operating Department Practitioner must make an entry in the CD Register clearly stating the reason for the entry and the corrected balance. This entry must also be witnessed by another healthcare professional (not student nurse) and both must sign the CD Register.

A liquid discrepancy is defined as + / -5% of the volume contained in the bottle.

 

8.5.9. How to Calculate Discrepancies

How to calculate 5%:

Look at the balance documented in the register and calculate 5% of this number.

Balance (mL)  x   5   =  5%
                         100

Example calculation:

Register = 60mL

60mL   x     5   =  3mL
                100

Volume range permitted is therefore:  57mL  <   60mL  >  63mL

*Remember discrepancy can be a shortage or an overage

If the discrepancy cannot be resolved, the Senior Charge Nurse or Midwife 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.

Pharmacy should be contacted and a DATIX report must be completed. All Incident Reports involving CDs must be tagged as a CD incident on DATIX to ensure the report is automatically forwarded to the CD Team within 24 hours (see Section 8.7.1.).


8.5.10. Clinical Trials

Where a Controlled Drug is being used in a clinical trial, all CD requirements (including, prescription, supply and storage) remain applicable and supersede any trial arrangements. The clinical trial must comply with the Misuse of Drugs regulations and local policies governing the management of clinical trial medicines, in addition to clinical trials legislation and MHRA guidance.

All clinical trial CDs should be stored separately from stock CDs, however, do not need to be stored in a separate CD Cabinet.

A separate page should be used in the CD Register as normal process.

A Home Office Licence must be obtained if a trial involves use of a Schedule 1 CD before the item is received into stock or supplied.  The licence should be held by the Accountable Officer. A copy of this licence must be kept with the trial protocol.

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Created: 01/12/21
Updated to add exanple forms: 27/05/22