Closed Consultations

Details of previous consultations conducted by the Pharmaceutical Society of Ireland (PSI). These consultations are now closed. It is our aim to publish an overview of the feedback received during consultations, and the PSI response to those.

2017

  • Consultation on Draft Guidelines for the Sale and Supply of Non-Prescription Medicinal Products

The PSI developed guidelines to aid pharmacist and pharmacy compliance with Regulations 5(1)(d), 5(1)(h) and 10 of the Regulation of Retail Pharmacy Businesses Regulations (S.I. No. 488 of 2008). It sets out the legal requirements for the sale and supply of non-prescription medicines from a pharmacy, whether occurring in-person, or at a distance through online purchases from a pharmacy's website. It includes guidance in relation to patient counselling, consultation and internet supply.

  • Review of the Code of Conduct for Pharmacists

During 2017, the PSI is reviewing the current Code of Conduct, which is a public declaration of the ethical standards that govern the practice of pharmacy in Ireland, and is applicable to all registered pharmacists.  First stage of the review began by inviting stakeholder comment and thoughts on the current Code during May and June, and a summary of that consultation will be made available here soon. A second stage of consultation will seek feedback on a revised draft Code later in the year. 


  • Consultation on Draft Joint Guidance: Safe Prescribing and Dispensing of Controlled Drugs 

The Medical Council of Ireland and the Pharmaceutical Society of Ireland (PSI) have come together, in a joint initiative, to examine patient safety matters of mutual concern and to make available practical guidance on the safe prescribing and dispensing of medicines that will be of use to both the medical and pharmacist professions.

The first joint guide is on the Safe Prescribing and Dispensing of Controlled Drugs and is a resource intended for use by all medical doctors and pharmacists in the collaborative, safe and effective care of patients, to facilitate safer prescribing and dispensing of controlled drugs.

  • Public Consultation on a draft PSI Corporate Strategy 2018-2020

As a public body, the PSI has an obligation to set out our strategy and its intended outcomes, and provide an opportunity for all those who are interested in or affected by our work to have a say in our future direction. In April, we sought feedback on a first draft of our next Corporate Strategy, setting out five key strategic areas where we propose to focus our development activities, and how we will go about meeting our core responsibilities, in the coming years.

2016

  • Public Consultation on draft Pharmaceutical Society of Ireland (Regulation of Temporary Absence Cover by Pharmaceutical Assistants) Rules 2016

Under the Pharmacy Act 2007 (the Act) it is an offence to operate a retail pharmacy business other than in accordance with particular conditions, one of which is that the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times (Section 26). However, the Act also provides that no offence is committed where a registered pharmaceutical assistant acts on behalf of a registered pharmacist during the temporary absence of the registered pharmacist (Section 30).

In circumstances where the registered pharmacist is temporarily absent from the pharmacy a registered pharmaceutical assistant may act on his/her behalf and carry out the functions of the pharmacist (excepting functions restricted to pharmacists under specific medicines legislation e.g. vaccination services).

In March 2016, the PSI consulted on the draft rules as to what constitutes the temporary absence of a pharmacist, as provided for under Section 30 of the Act. 

Consultation report of submissions received on the draft Temporary Absence Rules 2016

Further background information is also available on this topic.

Update

At its meeting on 23 March 2017, the PSI Council reviewed the responses received through the public consultation process on the draft Rules. The Council also listened to an address by Ms. Rita O’Brien, Chair of the Pharmaceutical Assistants Association, who addressed the Council at its invitation. The Council then proceeded to deliberate on the content of the draft Rules in light of the feedback received and with due consideration to its role as a public interest regulator. Following this consideration, the Council made the decision not to recommend the draft Rules to the Minister, under Section 30 of the Pharmacy Act 2007, and instead directed that the matters be re-examined with further consideration to be given to what could be covered within the scope of Rules, as provided for under Section 30 (2) of the Act. The Council acknowledged that the status quo position in relation to the 1994 Code of Practice still pertains.

  • PSI Customer Charter

We have developed a Customer Charter to provide you with information about the level of service you can expect from the Pharmaceutical Society of Ireland (PSI). As the pharmacy regulator, the PSI has a wide range of customers, who include, among others, patients, members of the public, registrants, other regulatory bodies, pharmacy students, the schools of pharmacy and policy makers.

  • Rules to receive evidence at a PSI Committee of Inquiry by video link

The PSI has drafted a statutory instrument (PSI Rules) which considers how evidence may be received and recorded by a PSI Committee of Inquiry, in particular so that the evidence of witnesses may be made by live video link or any other mode of transmission.  It is proposed that the Committee of Inquiry would decide in each instance about submissions made to it to receive evidence by live video link.

  • Public Consultation on draft Pharmaceutical Society of Ireland (Fees)(Amendment) Rules 2016

The fee payable by student pharmacists undertaking the in-service practical training programme, called the National Pharmacy Internship Programme, is €2,750. In line with the Government’s policy to increase the student contribution charge, which is capped at €3,000, the Council of the PSI has approved an increase in the programme fee to €3,000. The fee supports the delivery and quality of the training programme.

The Pharmaceutical Society of Ireland (Fees) Rules 2014 (S.I. No. 378 of 2014) set out the fees payable in respect of applications, notifications and services. An increase in the internship programme fee requires an amendment to those rules.

Read the draft Pharmaceutical Society of Ireland (Fees)(Amendment) Rules 2016.

Further details will be published here in due course.

  • Public Consultation on draft PSI Pharmacy Assessment System

A new Pharmacy Assessment System has been developed by the PSI, intended as a practical tool to facilitate the supervising pharmacist, superintendent pharmacist and pharmacy owner (those with management responsibility in a pharmacy) to reflect on their pharmacy’s practice and to identify areas for improvement. Read background information on this project.

Having developed the draft Pharmacy Assessment System and a guide to accompany it, a pilot among pharmacies to trial its use and to gather feedback was carried out, before its wider roll-out among all registered pharmacies.

  • Public Consultation on draft Guidelines on Record Keeping for Medicinal Products in a Retail Pharmacy Business

The PSI has developed draft guidelines setting out the legal requirements for keeping records when a prescription-only medicine or controlled drug is supplied from a pharmacy on foot of a prescription and in other circumstances. The purpose of the guidelines is to facilitate compliance with the record keeping requirements set out in Regulation 12 of the Regulation of Retail Pharmacy Businesses Regulations (S.I. No. 488 of 2008). 

Further details will be published here in due course.

  • Public Consultation on draft Guidance on the Provision of Vaccination Services by Pharmacists in Retail Pharmacy Businesses

Pharmacists have an important role to play in advising and educating the public about public health protection measures such as immunisation, as well as an important role in providing vaccination services. PSI Guidance on the Provision of Vaccination Services by Pharmacists was revised and updated in early 2016 to reflect changes under the Medicinal Products (Prescription and Control of Supply) (Amendment No.2) Regulations 2015, which authorises pharmacists to supply and administer two additional vaccines, the pneumococcal polysaccharide (PPV23) and herpes zoster (commonly known as shingles) vaccines.

Guidance on the Provision of Vaccination Services by Pharmacists in a Retail Pharmacy Businesses (final)

Consultation Report of the Public Consultation on this guidance

Read the draft revised Guidance on the Provision of Vaccination Services by Pharmacists in Retail Pharmacy Businesses.

  • Public Consultation on proposed amendments to the Pharmaceutical Society of Ireland (Fees) Rules, Pharmaceutical Society of Ireland (Registration) Rules, and Pharmaceutical Society of Ireland (Education and Training) (Integrated Course) Rules necessitated by changes to Directive 2005/36/EC.

The European Professional Qualifications Directive enables and facilitates the free movement of professionals, such as pharmacists, doctors and others, within the EU, by establishing a framework to facilitate the mutual recognition of professional qualifications.

On the 18 January 2016, changes to the European Professional Qualifications Directive (2005/36/EC) were implemented into Irish law. This required changes to national legislation and to the PSI’s Rules in relation to registration, education and fees in order to comply with changes arising from the directive. In January 2016 the PSI invited comment on the draft amending Rules.

Read this consultation document for an overview of the changes proposed to the PSI Rules relating to registration, education and fees.

Read the Amending Directive (2013/55/EU) and the Implementing Regulation (2015/983) and an overview (FAQ) of the new provisions of the Directive.

Consultation report and PSI responses to the submissions received.

Published PSI statutory instruments can be found on our legislation page.

      2015

  •  Public Consultation on a draft Patient Charter

We have developed a Patient Charter that we intend to publish in 2016, and during December 2015 we invited feedback on the draft document.

The PSI’s role is to act to protect and promote the health, safety and wellbeing of patients and the public and a Patient Charter. The Patient Charter is intended as a short, informative and accessible document for all pharmacy users.

Read about the aims of the Patient Charter

View the Patient Charter for public consultation

Consultation Report of the Patient Charter

  • Public Consultation on draft Guidance on Monitored Dosage Systems

The PSI issued draft Guidance for Pharmacists on the use of Monitored Dosage Systems in October 2015. The purpose of this guidance is to assist pharmacists in making appropriate decisions about whether a Monitored Dosage System (MDS) is suitable for a particular patient. The guidance also supports pharmacists when assessing which medicinal products are suitable for inclusion in the MDS and will outline all requirements needed of the retail pharmacy business, to ensure safe MDS dispensing occurs.

View and download the draft Guidance on the use of Monitored Dosage Systems.

Further details will be published here in due course.

  • Public Consultation on draft Guidelines on the Sale and Supply of Prescribed Medicinal Products from a Retail Pharmacy Business

The PSI issued draft Guidelines on the Sale and Supply of Prescribed Medicinal Products from a Retail Pharmacy Business in June 2015. The purpose of these guidelines is to facilitate compliance with the personal supervision requirements of the Pharmacy Act 2007 and the Regulation of Retail Pharmacy Businesses Regulations (S.I. No. 488 of 2008), and in particular, Regulation 9.

View the final Guidelines on Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business (October 2015)
Report on the Public Consultation on the draft Reg 9 Guidelines 2015
Click here to view the draft Guidance that was issued for consultation (June 2015)

  • Public Consultation on draft Guidance for Pharmacists on Extemporaneous Dispensing

The PSI issued draft Guidance for Pharmacists on Extemporaneous Dispensing for public consultation in February 2015. The Council of the PSI approved the final guidance at its meeting on 26th March 2015.

Final Guidance for Pharmacists on Extemporaneous Dispensing (June 2015)
Report on the Public Consultation on draft Guidance for Pharmacists on Extemporaneous Dispensing
Click here to view the draft Guidance that was issued for consultation (Feb 2015)

  • Public Consultation on the Pharmaceutical Society of Ireland (Continuing Professional Development) Rules 2015

In April and May 2015, the PSI undertook a public consultation on the new draft Pharmaceutical Society of Ireland (Continuing Professional Development) Rules 2015 relating to continuing professional development for pharmacists. The Pharmacy Act 2007 (as amended) confers a function on the PSI ‘to ensure that pharmacists undertake appropriate continuing professional development, including the acquisition of specialisation’. The Rules are necessary to give statutory effect to the PSI’s CPD model as agreed by the Council of the PSI in June 2010.

A copy of the draft Rules is available to view here.

Summary consultation report and PSI responses to the submissions received. All response data received to the consultation and statistical overview.

Published PSI statutory instruments can be found on our legislation page.

  • Public Consultation on draft Pharmaceutical Society of Ireland (Fees) (Amendment) Rules 2015

The Pharmacy Act 2007 has been amended to make it a principal function of the Pharmaceutical Society of Ireland to establish and maintain a list of persons entitled to supply non-prescription medicinal products via internet supply (entitled the ISS Supply List). This arises from Article 85c of the Falsified Medicines Directive (Directive 2011/62/EU) which introduces new EU wide regulatory controls on the supply of medicines by means of the internet. In Ireland this will apply to all those involved (pharmacies and non-pharmacies) in the internet supply of non-prescription medicines.The policy of the Council of the PSI is that the cost of this new regulatory system must be borne by those entities involved in the internet supply of non-prescription medicines and accordingly, a fee should be charged for entry on to the ISS Supply List. In this regard a public consultation was undertaken in April/May 2015 to consider a changed Fees Rule to incorporate an applicable fee. 

View Pharmaceutical Society of Ireland (Fees) (Amendment) Rules 2015 (S.I. No. 238 of 2015)

A copy of the draft Fees Rules is available to view here.

This explanatory note provides additional information.

  • Public Consultation on the Pharmaceutical Society of Ireland (Council) (Amendment) Rules 2015

The PSI undertook a public consultation in December 2014/January 2015 to consider changes to its Council Rules that amended procedures for the conduct of the elections of the President and Vice-President of the PSI Council, and for establishing arrangements for the formation of a panel of pharmacist candidates who are deemed to have been selected (Council election) by the members of the Society as being eligible for appointment to the Council in the event that casual vacancies arise on the Council.

A copy of the draft Rules is available to view here.

Click here to view submissions received during the consultation process and the PSI responses

Click here to view the final approved PSI (Council) (Amendment) Rules 2015

      2014

  • Public Consultation on draft Guidance on Data Protection for Pharmacists

    The PSI issued draft Guidance on Data Protection for Pharmacists for public consultation in June 2014. The Council of the PSI approved the guidance at its meeting on 2 October 2014.

    Final Guidance on Data Protection for Pharmacists (October 2014)
    Click here to view the consultation report
    Click here to view the draft Guidance that was issued for consultation (June 2014)

  • Public Consultation on draft Pharmaceutical Society of Ireland (Fees) Rules 2014 

    The Council of the Pharmaceutical Society of Ireland (PSI), at its meeting on the 27th March 2014, took a decision to reduce by 5% the first and annual registration fees payable by pharmacists, retail pharmacy businesses and pharmaceutical assistants. To give effect to this decision, it is necessary that the Council make Rules under section 11 of the Pharmacy Act 2007 (No. 20 of 2007). By virtue of section 11(6)(b) of this Act, the Council invited the public to comment on these draft Rules. This consultation closed on Friday 4th of July. 

         View Pharmaceutical Society of Ireland (Fees) Rules 2014 (SI 378 of 2014)       
         Click here to view submissions received and PSI responses.
         The draft Rules as issued for consultation are available to view here.

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