Inspectors' Advice on Balance Checks and Reconciliation in relation to Methadone Products

The CD register must be regularly reviewed to ensure the pharmacist can satisfy themselves that the register has been completed correctly for all controlled drugs including Methadone. This review should include the pharmacist carrying out a balance check to see if the balance recorded in the CD register reflects the volume of Methadone liquid present at the pharmacy.

Pharmacists should be aware that a manufacturer’s bottles of methadone liquid contain a small ‘overage’ in some cases. The extra liquid can result in a pharmacy having more Methadone than expected in certain circumstances. The purpose of this piece is to remind pharmacists to carry out their balance checks in regard to Methadone.

  • The frequency with which the CD register is reviewed should be determined by the Supervising Pharmacist. This may vary from pharmacy to pharmacy and will depend on the frequency of methadone dispensing, the volume of methadone dispensing, previous stock balance discrepancies etc.

  • To carry out a balance check, it is necessary for pharmacists to calculate the total volume of each Methadone product which is physically present at the pharmacy, including: 

    • a) The total volume of the full bottles of each Methadone product, and
    b) The total volume of open bottles of each Methadone product (a pharmacist is required to measure the actual volume of liquid contained in each open bottle of Methadone liquid using a graduated cylinder).

The total volume of Methadone liquid for each product (closed bottles plus open bottles) should then be compared against the balance recorded in the CD register for this product. 

  • When checking the Methadone balance, please remember to take account of any quantities of methadone supplied as instalments, which have been recorded on the patient’s prescription, but which have not yet been entered in the CD register.

  • If the actual volume of the liquid in stock differs from the running balance recorded in the CD register for a methadone product, it will be necessary to investigate the reason for the difference. The pharmacist should check to see if:
     - all receipts (invoices) have been correctly entered,
     - all supplies (prescriptions, requisitions) have been correctly entered,
     - any entries have been duplicated in error,
     - any other errors have taken place. 

  • If there is excess stock compared to the expected balance and the pharmacist is satisfied that this is due to ‘overage’ from manufacturer’s bottles, the running balance may be adjusted to reflect the current stock level. This entry should be signed by the pharmacist and annotated to show that the adjustment is the result of ‘overage'.

  • The details of any amendment to the CD register should be recorded in the footnote section at the bottom of the relevant page in the register. It may be necessary to demonstrate the workings of the reconciliation / investigation on a separate document. This should be retained with the CD register.

  • The Standard Operating Procedures (SOPs) at the pharmacy should clearly define the action that should be taken if a discrepancy between the CD register balance and the actual balance is identified, for example:
    - What action the pharmacist should take,
    - When and how the pharmacy owner or superintendent pharmacist should be notified, and
    - What records should be made. 

The PSI has produced Guidance for Pharmacists on the Safe Supply of Methadone (Undergoing update to reflect 1 March 2024 legislative amendments) which is also available on the PSI website. The PSI has also issued Advice on Controlled Drug (CD) Compliance. Relevant pharmacy and medicines legislation an also be found on the PSI website or www.irishstatutebook.ie

(This was included in Issue 9, 2014 of the PSI Newsletter)