Tommy Broughan (Dublin North East, Independent)
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559. To ask the Minister for Health the agency or body which has responsibility for calibrating the commercial methadone pumps which are used by pharmacies to dispense methadone; and if there is an operating procedure in his Department to invigilate and determine the standard of methadone pumps used in pharmacies. [49617/14]

Tommy Broughan (Dublin North East, Independent)
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560. To ask the Minister for Health if his attention has been drawn to discrepancies between the amount of methadone supplied by manufacturers or distributors to dispensing pharmacies and other methadone outlets; the amount of methadone prescribed to persons in receipt of opioid substitute treatment; if there is a record of any excess of methadone which is supplied to pharmacies and other methadone outlets by manufacturers or distributors but is not prescribed to persons in receipt of opioid substitute treatment. [49618/14]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 559 and 560 together.

The Pharmaceutical Society of Ireland (PSI) is the statutory body responsible for the regulation of the practice and profession of pharmacists in Ireland. PSI Guidelines on the Equipment Requirements of a Retail Pharmacy Business issued in draft form in 2012 and will be published in the PSI January 2015 Newsletter. These advise pharmacy practitioners that, “A high standard of equipment maintenance and cleanliness must be consistently applied. Equipment should be maintained, serviced and calibrated in accordance with the manufacturers’ instructions and records of such service and calibration should be kept.”

Currently within the HSE Addiction Treatment Centres the pumps that are used are calibrated by the company contracted to provide methadone to the services. The pumps are calibrated every six months to ISO standards by an external calibration agency. Each of the centres has Standard Operating Procedures for calibration and maintenance of the pumps.

In community pharmacy, pumps are not universally used for the measurement of methadone. Many community pharmacies use CE marked graduated cylinders in general and decant from 500 ml bottles, with the exception of some high volume dispensaries that may use a pump system.

The Misuse of Drugs Regulations 1988 (S.I. No 328 of 1988) requires pharmacies to maintain a Controlled Drugs (CD) Register in respect of all drugs, including methadone, listed in Schedule 2, with a running balance. Inspections are carried out by the PSI, under Section 67 of the Pharmacy Act 2007. The sale and supply of all Schedule 2 controlled drugs and the manner in which the CD Register is maintained are checked as part of these inspections. The register is reviewed to see if running balances are properly maintained.

Manufacturers’ bottles of methadone liquid contain a small ‘overage’ in some cases. The volume declared would be the nominal volume. In other words, if the label states 500 ml then at least 500 ml must be available for administration. That is the standard for medicines, and this means that a slight excess is included to allow the correct volume to be withdrawn. There is no upper limit in the pharmacopoeias (standards).

The extra liquid can result in a pharmacy having more methadone than expected in certain circumstances, and this should be accounted for through the regular balance checks and reconciliation. To assist pharmacists in maintaining the CD register for methadone products, PSI Inspectors have provided advice that is now available on the PSI website - . This advice states that 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. Excess methadone is always accounted for with the CD register per the guidance that has been issued to account for ‘overage’.

If there is excess stock compared to the expected balance and the pharmacist is satisfied that this is due to ‘overage’ from manufacturers’ 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' and their calculations documented in the CD register.

The latest figures available show that a total quantity of 142,119,673 mls of methadone was dispensed through community pharmacies in 2013 for palliative care and for the treatment of opiate dependency. The total quantity of methadone dispensed through the HSE addiction centres for the treatment of opioid dependency was73,530,249 mls of methadone.