1781. Deputy David Cullinane asked the Minister for Health the latest guidelines and regulations which govern the sale and supply of codeine containing products by retail pharmacy businesses; when these were last reviewed; and if he will make a statement on the matter. [18269/23] 

1785. Deputy David Cullinane asked the Minister for Health the number of inspections conducted by the Pharmaceutical Society to ascertain compliance with guidelines for the safe dispensing of non-prescription products containing codeine by retail pharmacy businesses in each year since establishment, by purpose, in tabular form. [18273/23]

 1786. Deputy David Cullinane asked the Minister for Health the number of enforcement actions, or actions otherwise taken to correct or address poor practice, behaviour, or performance by pharmacists or by pharmacies, taken by the Pharmaceutical Society to address compliance with guidelines for the safe dispensing of non-prescription products containing codeine by retail pharmacy businesses in each year since establishment, by action type and grounds, in tabular form. [18274/23] 

1787. Deputy David Cullinane asked the Minister for Health the level of compliance with the 2010 Pharmaceutical Society guidelines on the safe dispensing of non-prescription products containing codeine by retail pharmacy businesses. [18275/23] 

Stephen Donnelly, Minister for Health: I propose to take Questions Nos. 1781 and 1785 to 1787, inclusive, together. 

The Pharmacy Act 2007 and the Regulation of Retail Pharmacy Businesses Regulations 2008 require that all medicines supplied through a pharmacy must be supplied by or under the personal supervision of a pharmacist and that all non-prescription medicines supplied must be the subject of appropriate counselling. Pharmacists are also subject to a mandatory Code of Conduct, which is a public declaration of the principles and ethical standards which govern pharmacists in the practice of their profession. The code requires that pharmacists only supply or promote a product or service where the benefit of use outweighs the risk and there is appropriate evidence of efficacy.

As an analgesic, codeine is most often used in combination with other analgesics such as paracetamol or ibuprofen and is currently authorised in Ireland in such non-prescription products for pain relief. It is also available in single ingredient, non-prescription products, as a cough suppressant. These authorised products are available without a prescription through retail pharmacy businesses (pharmacies) only. 

The pharmacy regulator, the Pharmaceutical Society of Ireland (PSI), issued guidance to pharmacists in 2010 on the safe supply of non-prescription products containing codeine with the intent to support safe and appropriate use of these products for public health purposes due to the known potential for misuse and harm with prolonged use. This guidance was updated in 2015, 2017 and most recently in October 2019 due to changes in national legislation. The Guidance covers the requirements set out above and, in addition, contains further restrictions which apply to the supply of codeine-based products. 

These restrictions include a requirement that codeine-based products are not available to the public for self-selection and should only be supplied when a pharmacist deems such a supply to be necessary and only when a non-opioid analgesic, e.g. paracetamol, aspirin or ibuprofen, has not proven sufficient to relieve the patient’s symptoms. The guidance also states that codeine medicines should be used for the shortest time possible and for no longer than three days without medical supervision. Pharmacists must also ensure that patients are advised of the importance of adhering to the recommended dosage and duration of use, as well as the risks associated with overdose and/or prolonged use. Patients should also be counselled in respect of potential adverse reactions or side effects. 

The full guidance document, along with information on current legislative requirements, is available on the PSI website: Non Prescription Medicinal Products Containing Codeine 2019 

The PSI uses a variety of regulatory actions to promote and enforce compliance in line with its remit as the pharmacy regulator. This includes information gathering, inspections and investigations, handling complaints made by members of the public about a pharmacist or pharmacy, and sharing information that promotes safe pharmacy practice, and effective and reliable patient care. Visiting pharmacies to assess compliance with pharmacy and medicines legislation and PSI guidance, is one way that the PSI seeks to assure a high standard of compliance in pharmacies to maintain public health, safety and confidence in pharmacy care and services. The PSI carries out different inspection activities including routine inspections, themed inspections and mystery shopper exercises. Pharmacy inspections are also underpinned by the requirement that the supervising pharmacist in each pharmacy is responsible for completing each section of a Pharmacy Assessment System once annually, and PSI inspectors will look for action plans derived from the completion of this activity during an inspection. Further information is provided in the PSI Inspection Enforcement_Policy.sflb.ashx (thepsi.ie) and other information may be accessed at www.thepsi.ie/gns/inspection-enforcement/overview.aspx including the routine checklists used to underpin these activities. 

The PSI has a number of actions it may utilise should concerns arise in respect of any activity of a pharmacy ranging from the issuing of advice to the taking of prosecutions in the District Courts and/or the Conduct of a fitness to practice hearing. Anyone is entitled to make a complaint to the PSI where there is concern about the behaviour, conduct, practice or health of a pharmacist. The PSI publishes the outcomes of fitness to practice proceedings in accordance with its Publications and Disclosure Policy (2022) available at www.thepsi.ie/Libraries/Findings_and_Decisions/Publication_and_Disclosure_Policy_2022.sflb.ashx 

During all registration-related inspections and pharmacy systems inspections, the PSI reviews the availability and implementation of standard operating procedures (SOPs) for the sale and supply of codeine-containing medicines and ensures that codeine is not accessible and/or visible to patients and the public, in accordance with PSI Guidance on the safe supply of codeine containing medicines. Any non-compliances identified at pharmacy inspections are recorded and corrective actions are sought from the registrant. 

Self-Audit – Pharmacy Assessment System 

Pharmacy inspections are underpinned by the requirement that the supervising pharmacist in each pharmacy is responsible for completing each section of a Pharmacy Assessment System once annually, and PSI inspectors will look for action plans derived from the completion of this activity during an inspection. This practical self-audit tool facilitates those in governance positions to critically review their pharmacy’s practice, validate and record good practice and identify areas where improvements are required. Section 2 of the Guide to completing the Pharmacy Assessment System, refers to advice on reviewing the sale and supply of non-prescription medications including codeine. Further information is provided in the PSI InspectionEnforcement_Policy.sflb.ashx (thepsi.ie) and other information may be accessed at www.thepsi.ie/gns/inspection-enforcement/overview.aspx including the routine checklists used to underpin these activities.

Table 1 below highlights the number of concerns received by the PSI relating to codeine (n=8) which required follow-up. A range of measures were taken by PSI in response to these concerns.

From 2013, the PSI has engaged specialist surveyors as part of its regulatory tools and engagement with pharmacists and pharmacies, for example, to assess certain quality and safety aspects of specific pharmacy services, including the review and assessment of the sale and supply of non-prescription codeine containing medicinal products. (No specialist surveyor activity was conducted between 2020-2021 due to the COVID-19 pandemic). 

The observations from these specialist surveyor activities help the PSI identify, measure, and respond to any relevant risks presenting. The activities are followed up by PSI with engagement with the relevant pharmacies and pharmacists, highlighting any issues identified, as well as more broadly raising awareness and highlighting any matters for compliance amongst the whole registrant population by sharing information by newsletter and email. As recently as October 2022 and March 2023, reminders about the PSI codeine guidance, and the responsibilities of pharmacists in relation to the safe and appropriate supply of codeine products to patients, were highlighted in the PSI Newsletter. Pharmacists play a key role in raising public awareness and understanding about the benefits and risks of medicines. 

The use of specialist surveyors to assess aspects of specific pharmacy services have been found to be effective both from a resource and cost perspective, combined with all other work being undertaken. Most recently in 2017 and 2022, 80 and 100 pharmacies respectively were visited by specialist surveyors to examine the sale and supply of non-prescription codeine containing medicinal products from these pharmacies.