Home > Dail Eireann debate. Written answer 427 - Pharmacy services [Methadone] [47750/13].

[Oireachtas] Dail Eireann debate. Written answer 427 - Pharmacy services [Methadone] [47750/13]. (12 Nov 2013)

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427. Deputy Thomas P. Broughan asked the Minister for Health if he will provide the number of pharmacies dispensing methadone which have been inspected by the Pharmaceutical Society of Ireland in the years 2011, 2012 and to date in 2013; the number of those pharmacies inspected which had an incorrect register balance or no running balance. [47750/13] 

Minister of State at the Department of Health (Deputy Alex White): 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 listed in Schedule 2, including methadone. All entries must be recorded in a chronological sequence and in a manner which shows a running balance.

 

Inspections are carried out by the Pharmaceutical Society of Ireland (PSI) under Section 67 of the Pharmacy Act 2007 to review compliance with the Act, regulations made thereunder and medicines legislation. 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. The physical inventory of three controlled drug preparations is counted during each inspection. The physical tally is then checked against the balance indicated in the CD Register to see if they match. The manner in which the findings are reported does not differentiate the record keeping requirements observed for methadone from other Schedule 2 controlled drugs.

 

As part of the registration process for retail pharmacy businesses, pharmacy owners and Superintendent Pharmacists are required to notify the PSI if the pharmacy concerned is engaged in the sale or supply of methadone. As at 7th November 2013 records indicate that 753 Pharmacies are engaged in the sale and supply of methadone.

 

To date in 2013, the results of 364 pharmacy systems inspections were recorded in the PSI inspection database. These show that 37 pharmacies failed to record or properly record the running balance in respect of one or more Schedule 2 controlled drugs in the CD Register, and in 104 cases the physical inventory did not agree with the balance specified in the Registers.

 

In 2012, 75 pharmacy systems inspections were carried out, of which 59 were recorded in the inspection database when it went live during the year. The results show that 4 pharmacies failed to record or properly record the running balance in respect of one or more Schedule 2 controlled drugs in the CD Register, and in 8 cases the physical inventory did not agree with the balance specified in the Registers. The records of those pharmacies notified to the PSI as selling or supplying methadone for 2011 and 2012 are held in paper copy only and a review of all 1,600 paper files would be required to establish the number of pharmacies that supplied Methadone at that time. The data obtained during inspections in 2011 was not recorded on a computer database, and accordingly detailed information regarding regulatory compliance with the requirement to maintain the CD Register is not readily available for 2011.

Item Type:Dail Debates
Source:Oireachtas
Date:12 November 2013
EndNote:View
Subjects:B Substances > Opioids (opiates) > Opioid product > Methadone
HJ Treatment method > Substance disorder treatment method > Substance replacement method (substitution) > Methadone maintenance
J Health care, prevention and rehabilitation > Health care programme or facility > Community-based treatment (primary care)
T Demographic characteristics > Pharmacist
VA Geographic area > Europe > Ireland

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