Tommy Broughan (Dublin North East, Independent)
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411. To ask the Minister for Health further to Parliamentary Question No. 427 of 12 November 2013, the sanctions in place for pharmacies which failed to record or properly record the running balance in respect of one or more schedule 2 controlled drugs in the CD register and for pharmacies which were found to have physical inventories which did not agree with the balance specified in the registers. [40006/14]

Tommy Broughan (Dublin North East, Independent)
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412. To ask the Minister for Health further to Parliamentary Question No. 427 of 12 November 2013, if he will provide up to date figures on the number of pharmacies dispensing methadone which have been inspected by the Pharmaceutical Society of Ireland in November and December 2013 and to date in 2014; and the number of those pharmacies inspected which had an incorrect register balance or no running balance. [40007/14]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 411 and 412 together.

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 (the Act) 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 of 20^thOctober 2014, records indicate that 797 pharmacies are engaged in the sale and supply of methadone. These figures are contingent on the accuracy of the information provided by the registrants.

From 1^stNovember 2013 to the 20^thOctober 2014, 546 pharmacy systems inspections were recorded in the PSI inspection database. These show that 84 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 115 cases the physical inventory did not agree with the balance specified in the Registers.

Once an inspection is completed, a report is issued to the registrant. The report cites both compliances and non-compliances. The registrant is required to respond to the report within a given timeframe and to confirm that each of the non-compliances identified in the report has been addressed. As part of the response registrants review and investigate deficiencies and, where appropriate, provide evidence and explanations in respect of particular matters noted. In some cases they may provide evidence/documents in support of explanations furnished. In the majority of cases, these explanations lead to the closure of the matter. In certain cases, re-inspections are directed to confirm that matters have been addressed. In 2013, one report which identified non-compliances with controlled drugs legislation, together with other non-compliances, was referred to the complaints process operated under Part 6 of the Act.

Certain inspection reports are considered by the PSI Council under section 71 of the Act (in Part 7 of the Act, which refers to Powers of Investigation). Following the consideration of a report the PSI Council may direct the Registrar to:

-Take no action

-Make a complaint against a pharmacist/(s) or a pharmacy owner

-Take such other action as is considered appropriate. This includes initiating prosecutions, directing re-inspections, seeking undertakings, deferral of decision pending undertakings.

In 2013, 388 routine inspections were carried out. Approximately 10% of these reports were considered pursuant to section 71 of the Act. The following is an approximate breakdown of the actions taken further to consideration of these reports, (noting that these are global figures and do not relate exclusively to breaches of controlled drugs legislation):

-67% - Decision to re-inspect the pharmacy/Deferral of Decision pending re-inspection

-27% - Take no action

-6% - Other (This includes 1 complaint which was made against a pharmacist).