Frequently Asked Questions (FAQs)

Prescriptions written by doctors outside of the EU/EEA are not legally valid in Ireland and legislation does not facilitate emergency supplies of medicines to these patients.  If presented with such a prescription, you should explain this to the patient and refer them to another appropriate healthcare professional or service for further care. 

A prescription issued for a high-tech medicine is subject to the same legal controls as any other prescription. The maximum validity period for any prescription issued (excluding schedule 2 and 3 controlled drugs) is six months from the date of issue. This ensures that the patient receives ongoing clinical review at appropriate intervals and is central to ensuring the safe use of these medicines. Some high-tech prescriptions may specify an earlier date of patient review and care must be taken to ensure the prescriber’s instructions are correctly interpreted and followed. A prescription dispensed outside its expiry date can result in the patient not receiving the necessary clinical review, which could potentially result in harm to the patient.      

This information is contained in the PSI’s guidance Good Dispensing Practice – High Tech Scheme.   

The high-tech scheme is a government reimbursement scheme which falls under the jurisdiction of the HSE. Any pharmacist participating and delivering care to a patient under this scheme must ensure that they adhere fully to the operational requirements provided by the HSE.   

Under this scheme the HSE requires that high tech medicines are initiated by a consultant doctor, who is responsible for overseeing the patient’s therapy and care, and therefore their review at appropriate intervals, depending on the clinical particulars.   

If the date of review of therapy specified by the consultant on the high tech prescription is for a period that exceeds 6 months and the GP is satisfied that it is appropriate for the patient to continue to take the medicine, they can issue a prescription for the high tech medicine provided that the product is for use within the specified review date.  The GP would be accepting responsibility for this supply and must be satisfied that it is safe and appropriate for the patient when each prescription is issued. 

This is set out in the PSI’s guidance Good Dispensing Practice – High Tech Scheme.   

The PSI’s Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business (Version 4 March 2024) contains relevant information on how long records must be retained under legislation. The requirements for some other important records that promote safe pharmacy practice are also included. 

The PSI’s Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business sets out the legal requirement to maintain a patient medication record (PMR). The legislation does not specify a minimum or maximum time period for the maintenance of this record. However, data protection legislation applies to all patient related pharmacy records.

When developing and maintaining policies on the retention of records, as well as complying with the requirements set out in legislation, it is important to consider whether it is necessary to retain the record for a longer period to ensure the provision of safe services to patients, or for other legal or insurance purposes. Data protection requirements also require that there be a defined retention period for all records, which is clearly documented. 

Pharmacists and pharmacy owners should seek the advice of the Data Protection Commission and/or their legal advisors if they have questions regarding specific issues.  

The prescription writing requirements for schedule 2, 3 and 4 Part 1 controlled drugs are set out in Regulation 15 of the Misuse of Drugs Regulations 2024 (as amended) Prescriptions which meet the prescription writing requirements of Regulation 15 of the Misuse of Drugs Regulations, are valid for dispensing under Regulation 16 of the Misuse of Drugs Regulations, where they meet the additional criteria set out under Regulation 16.   

Prescriptions for controlled drugs can be written privately or on a “Health prescription” which is also referred to a to as a GMS (General Medical Services) prescription.   

Prescriptions can be paper-based or transferred through the national electronic prescription transfer system, also referred to as Healthmail.

Where a Schedule 2 or 3 Controlled Drug prescription is transferred through Healthmail, the specific prescription writing requirements still apply, however, these do not need to be in the prescriber’s own handwriting. As a prescription sent through Healthmail is traceable back to the prescriber, a signature is not required on the prescription. However, the pharmacist must still be satisfied that in their professional judgement it is safe to make any supply in the context of the information received. Examples of controlled drug prescriptions and a reference table are provided below.

For further information please refer to the joint guidance produced by the Medical Council and the PSI on Safe Prescribing and Dispensing of Controlled Drugs.   

We have also issued Advice on Controlled Drug Compliance, which you may find helpful.   

The Health Products Regulatory Authority (HPRA) is the regulator of medicinal products, and the body that determines the legal classification of each medicinal product on the Irish market. You can check the legal classification of a medicinal product through the ‘Find a medicine’ facility on HPRA’s website. If you search for a particular medicine, the legal classification of the individual medicinal product is then provided under the heading ‘Status’ and the subheadings ‘Dispensing Status’ and ‘Conditions of licence’.   

Alternatively you can contact the HPRA on +353 1 676 4971 or info@hpra.ie.  

The PSI provides controlled drugs registers to registered pharmacies and pharmacists to assist them in complying with the requirements set out in the Misuse of Drugs Regulations 2017. The PSI does not supply controlled drug registers to other organisations.    

The end of the PSI Controlled Drugs Register includes a section for recording the destruction of schedule 2 controlled drugs, which require witnessed destruction (e.g. schedule 2 controlled drugs which have expired or been damaged).  The PSI also provides a Controlled Drugs Destruction Record Book for recording the destruction of schedule 3 or 4 controlled drugs or ‘patient-returned’ schedule 2, 3 or 4 controlled drugs (i.e. controlled drugs that do not require witnessed destruction).     

Pharmacists can order a controlled drug or duty register by filling out an online form. All orders received will be processed within ten working days.    

Some pharmacies have developed their own customised registers which better suit their particular needs and these are equally acceptable, provided they meet all relevant legislative requirements detailed in the Misuse of Drugs Regulations 2017 (as amended).   

Detailed guidance on the record keeping requirements for drugs is contained in the Register of Controlled Drugs provided by the PSI, and in the   

PSI Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business    

The following advice may also be useful:   

• Any corrections entered in the CD Register must be made by footnote (correction fluid and alterations to entries are not permitted).   
• Previously dispensed controlled drugs returned to the pharmacy must never be re-introduced into stock and/or re-used. The destruction of these medicines should be recorded in the designated Controlled Drugs Destruction Record Book provided by the PSI.   
• Don’t forget to reconcile the balance indicated in the register against the physical stock located in the CD Safe on a regular basis. Pages 12/13 of the PSI CD Register can be used to record regular accuracy checks by the supervising pharmacist.   
• Invoices for Schedule 3, Schedule 4 Part 1 and Schedule 5 controlled drugs must be kept for a period of two years and it is recommended that they are kept on the pharmacy premises.   
• All prescriptions for Schedule 2 and Schedule 3 controlled drugs, including GMS duplicate prescriptions, must be retained on the premises for two years. Where the prescription is transferred through Healthmail, the prescription must be printed and retained in the same manner as a paper-based prescription. Electronic version of Healthmail prescriptions must also be retained at the pharmacy premises for a period of two years.   
• Where a paper-based prescription for a Schedule 4 Part 1 controlled drug has been indicated by the prescriber to be repeated, and where the prescription is not exhausted, pharmacists are required to keep a copy of the prescription (including a copy of any endorsements made on the prescription- this may include a scanned copy) on the premises for two years after the date of supply.   
• Where a paper-based prescription for a Schedule 4 Part 1 controlled drug has been exhausted, the prescription must be retained on the premises for two years.   

All Schedule 2 controlled drugs (CD2s) must be stored in the safe. This includes Methadone preparations. See PSI Guidance for Pharmacists on the Safe Supply of Methadone and Buprenorphine for Opioid Substitution (Undergoing update to reflect 1 March 2024 legislative amendments). All Schedule 3 controlled drugs (CD3) must be stored in the safe. This includes temazepam (e.g. Nortem®, Tenox®, etc) preparations. The safe custody requirements for Schedule 2 and 3 controlled drugs do not apply to Schedule 4 Part 1 controlled drugs.   
   
Expired or non-conforming (e.g. damaged) Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock and clearly labelled ‘CDs for destruction'. Expired or damaged Schedule 2 CDs should be destroyed in the presence of an authorised person i.e. member of An Garda Siochana or PSI Inspector.   
   
Patient-returned CDs should be promptly destroyed. While awaiting destruction, patient-returned Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock and clearly labelled ‘Patient-returned CDs for destruction'.   
   
To meet safe custody requirements, all safes for the storage of controlled drugs must be secured to a concrete wall or floor. If the safe does not bear the inscription I.S. 267:1985, the safe must be certified by a Garda Superintendent. Remember to retain this certificate at the pharmacy. Ideally this safe should be located out of the line of sight of the public. These requirements can be found in SI 321/1982 - Misuse of Drugs (Safe Custody) Regulations, 1982.

Regulation 16 of the Misuse of Drugs Regulations 2017 (as amended) states that all instalments must be dispensed at stated intervals within 2 months from the date of the prescription.   
   
Therefore, if all instalments are dispensed at the specified intervals and the final instalment is within the 2 month time frame, it is acceptable to dispense all 3 supplies to the patient. It is important to remember the first instalment must always be dispensed within 14 days from the date on the prescription.

Information on the destruction of controlled drugs can be found in the PSI Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business.   

Section 3.2 of these guidelines outlines the specific requirements for the destruction and disposal of schedule 2, 3 and 4 controlled drugs.

The PSI provides controlled drug registers to pharmacies and pharmacists to assist them in complying with the requirements set out in the Misuse of Drugs Regulations 2017. The PSI do not supply controlled drug registers to other organisations.   

The back of the PSI controlled drug register includes a section for recording the destruction of schedule 2 controlled drugs which require witnessed destruction (e.g. schedule 2 controlled drugs which have expired or been damaged).  The PSI also provide a Controlled Drugs Destruction Record Book for recording the destruction of schedule 3 or 4 controlled drugs or ‘patient-returned’ schedule 2, 3 or 4 controlled drugs (i.e. controlled drugs that do not require witnessed destruction).    

Pharmacists can order a controlled drug, destruction or duty register by filling out an online form. All orders received will be processed within seven working days.   

Some pharmacies have developed their own customised registers which better suit their particular needs, and these are equally acceptable, provided they meet all relevant legislative requirements detailed in the Misuse of Drugs Regulations 2017.   

The PSI does not provide veterinary registers. Some animal remedy wholesalers have provided animal remedy registers to pharmacies in the past. Information on what must be recorded is set out in the European Communities (Animal Remedies) (No.2) Regulations 2007 (S.I. No. 786 of 2007) (as amended).   

All pharmacists engaging in the sale and supply of animal remedies should ensure that they are familiar with these regulations.

The HSE warfarin information packs can be ordered directly from KPW Print in Ballinasloe, Co. Galway. The patient information packs contain an alert card, record book and information on dental visits. Record books are also available for order separately.   

For further details, including pricing, you can contact KPW Print on 090 9642297.   

Saint John of God Hospital has developed a national lithium patient information booklet to support improving patient safety in the use of lithium therapy. This can be found on the Saint John of God Hospital website.  

The PSI no longer provide these cards, however if you require a copy of the original templates, please contact info@psi.ie. Please note that these cards and their use and content should be reviewed and amended as necessary by the pharmacist before use, on an individual patient basis, to ensure that the information being provided is in line with current best clinical practice.   

The PSI does not accept liability for the content of these cards.

Following commencement of the Health (Regulation of Termination of Pregnancy) Act 2018, termination of pregnancy services are available in Ireland since 1 January 2019. Abortion services are being provided by the HSE, through GPs or family planning services, and in maternity units and hospitals.   

Pharmacists will primarily be involved in the supply of medicines to the GP/ family planning service (via a HSE stock order). Further information on this process and the medicines involved is available from the HSE. Queries from pharmacists on this service should be directed to Pharmacy.Response@hse.ie. Pharmacists, as part of their usual professional role, should facilitate the safe use of medicines and support appropriate patient care in the provision of this service.   

Further information on unplanned pregnancy support services, including resources for healthcare professionals and information on termination of pregnancy services is available on the HSE website, myoptions.ie. Patients can also be directed to the My Options freephone line on 1800 828 010 for support.   

The statutory Code of Conduct for pharmacists sets out the principles for professional practice and behaviour which patients, members of the public, other healthcare professionals and society require and expect of pharmacists who are registered with the PSI. The Code of Conduct is intended to provide support and guidance to pharmacists as they discharge their professional duties.   

The Code requires pharmacists to ensure that in instances where they are unable to provide prescribed medicines or pharmacy services to a patient or another healthcare professional, they must take reasonable action to ensure those medicines or services are provided and that the patient’s care is not jeopardised.   

The Department of Health has published an online repository of information on medical cannabis. It provides detailed information on the existing Ministerial medical cannabis licence scheme, the Medical Cannabis Access Programme currently under development, and relevant legal and policy overviews on wider medical cannabis issues. Patients, members of the public and other healthcare professionals interested in finding out about cannabis for medical use can be referred to the online repository.   

The Department of Health will continue to add information on further developments in this area to the online repository to keep healthcare professionals and patients up to date.

The General Data Protection Regulation (GDPR), which came into force on 25 May 2018, enhances the rights of individuals in relation to the protection of their personal data and places greater responsibilities on organisations/businesses about how they treat personal data. At the centre of the new law is the requirement for organisations and businesses to be fully transparent about how they are using and safeguarding personal data, and to be able to demonstrate accountability in relation to the data protection principles now in place.   

Given the sensitivity of health-related information, it is imperative that healthcare professionals are clear about their use of personal data and continue to consider and maintain the confidentiality of patients’ information. Therefore, all pharmacies must have proper data protection arrangements in the interest of their patients, as well as their employees. Any employed pharmacist should expect to work in line with their employer’s governance arrangements in relation to the updated data protection requirements and be supported to do so.   

Changes under GDPR and data protection legislation, mean that the previously published PSI Guidance on Data Protection for Pharmacists is no longer current. Following a review, we have taken the decision not to replace the guidance, which was designed originally to give pharmacists some support in their compliance with data protection legislation. The guidance has been removed from our website, and you should also remove the guidance from the Pharmacy Practice Guidance folder in your pharmacy.   

The Data Protection Commission is responsible for upholding the rights of individuals in relation to their data processing. Both the Commission’s own website and their GDPRandYou website have extensive information and resources available about data protection rights and responsibilities, and the Data Protection Commission also accepts queries via their website. The PSI is not able to give advice to others about data protection.   

The requirements for the recording of sales of scheduled poisons are set out in the Poisons Regulations 2008. Schedule 5 sets out the entry to be made in a record book to be kept in accordance with the regulations. These records should preferably be kept in a hardback book. The PSI does not provide poisons registers.   

The list of required fields to be entered in a Poisons Register are:   

1. date of sale;   
2. name and quantity of poison sold;   
3. name and address of purchaser;   
4. trade, business or occupation of purchaser;   
5. purchaser’s statement of the purpose for which poison is required;   
6. date of certificate, if any;   
7. name and address of person giving certificate, if any;   
8. signature of purchaser (or, where 7. a signed order is presented, the words “signed order” with the appropriate reference number).   
    

The sale of methylated spirits is subject to the Intoxicating Liquor Act 1924. Methylated spirits may only be supplied by:   

• authorised methylators   
• persons licensed to sell methylated spirits   

A licence from the Customs and Excise is required to authorise the supply of methylated spirits to the public. Any pharmacist wishing to sell methylated spirits must obtain such a licence, which is renewable annually. Information and application forms are available on the Revenue website.   

Stocks of methylated spirits held by a licensed retailer should not exceed 18.5 litres at any one time, nor should any one sale or supply exceed 18.5 litres. Sales between 9pm on Saturday evening and 9am on the following Monday morning are prohibited. The purchaser should be known to the seller or vouched for by a person known to the seller. The purchaser must state the purpose for which the spirits are required. At the time of sale, the retailer must enter certain details into the methylated spirits register.   

Details to be recorded in Methylated Spirits Register:    

• the name and address of purchaser;   
• purpose for which the spirits is required, as stated by purchaser;   
• the quantity of spirits sold,   
• the date of sale.   

A signature is not required.   

The methylated spirits register should be kept at the licensed premises, for example, the pharmacy, and be readily available for inspection by members of the Garda Síochána, members of the Customs and Excise, or other authorised inspectors.   
 
The PSI does not provide methylated spirits registers.   

The Medicinal Products (Prescription and Control of Supply)(Amendment) Regulations 2020 (S.I. No. 98 of 2020) defines the National Electronic Prescription transfer system as “a system providing for the transfer of prescriptions, in permanent and unalterable form, by electronic means approved, on behalf of the Health Service Executive, by the head of the Primary Care Reimbursement Service (PCRS) and the Chief Information Officer”. The approved system is the HSE’s Healthmail System.   

Any pharmacy not already registered with Healthmail and who wish to do so will find further information on the Healthmail website.   

Healthmail also allows for the transfer of prescriptions to pharmacies from hospitals and health agencies who are securely connected to Healthmail. Please refer to the Healthmail Registration Portal- FAQ's for further information. This means that a prescriber in a Healthmail connected agency (for example, a HSE Hospital) can send a prescription securely to a Healthmail user (for example, a community pharmacy).

No. To be legally valid a prescription sent through Healthmail must:   

• be in electronic form,   
• be transmitted by the national electronic prescription transfer system,   
• clearly indicate the date of issue,   
• clearly indicate the professional registration number of the prescriber, and   
• be traceable electronically back to the prescriber.   

A prescription sent through Healthmail is traceable back to the prescriber and therefore a signature is not required on the prescription. The pharmacist must still be satisfied that in their professional judgement it is safe to make any supply in the context of the information received.   

All other prescription requirements under the relevant legislation must still be met for prescriptions sent through Healthmail, including those relating to opioid substitution prescriptions which must be prescribed using the opioid substitution prescription form.    

PSI, Medical Council and HSE joint guidance provides more detail about the changes introduced under the emergency regulation amendments.

A prescription/communication sent outside the National Electronic Prescription Transfer System is not recognised in the legislation as a legally valid prescription, for example, prescriptions sent through personal or commercial email accounts or fax.   

Prescription only medicines, including Schedule 2, 3 and 4 controlled drugs can be supplied on foot of a prescription which is:

1. Paper-based – written in ink, signed by the prescriber in his or her usual signature, and dated by him/her) or,
2. Electronic - transmitted by the national electronic prescription transfer system, indicating the date of issue, the professional registration number of the prescriber, and traceable electronically back to the prescriber.   

Faxed copies of prescriptions do not constitute an original prescription and may only be used as supportive information in relation to facilitating emergency supplies at the request of a prescriber and where in the exercise of their professional judgement the pharmacists deem it safe, and appropriate to do so.   

Yes. This means that a prescriber in a Healthmail connected agency can send a prescription securely to a Healthmail user i.e. a community pharmacy.   

In addition, all HSE hospitals, primary care teams or health care professionals who have an @hse.ie email address can send a prescription securely to a pharmacy’s Healthmail account. Prescriptions sent from one of these domains to a healthmail address is still sent via healthmail, as is required under the legislation, and healthmail remains a closed system. 

A prescription sent outside the Healthmail system is not recognised in the legislation as a legally valid prescription, for example, prescriptions sent through personal or commercial email accounts or fax. In cases where pharmacists receive prescriptions by other electronic means, in relation to an emergency supply at the request of a prescriber, the original prescription must still be received by the pharmacy within 72 hours in accordance with the emergency supply provisions of Regulation 8 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended).   
   
For assistance with Healthmail specific queries, visit the FAQs section on the Healthmail website. Contact details for Healthmail can also be found on their website.   

A) Emergency Supply of Prescription Only Medicines   

A pharmacist can provide an emergency supply of a prescription only medicine based on a request from a prescriber (registered medical practitioner, registered dentist, or registered nurse). This is allowable in emergency situations where the prescriber is unable to supply the prescription immediately but undertakes to provide it within 72 hours. The pharmacist may make the supply in accordance with the prescriber’s instructions, including the quantity to be supplied.  

A pharmacist can provide an emergency supply of a prescription only medicine based on a patient’s request, where they have interviewed the patient and are satisfied that there is an immediate need for the supply, it is impracticable to obtain a prescription without undue delay, the treatment has previously been prescribed for the patient (by a medical practitioner, registered dentist, or registered nurse), and the appropriate dose can be verified. Emergency supplies made on foot of a patient request may be of quantity that provides up to 5 day’s treatment or the nearest equivalent minimum dosage pack unit.  

B) Emergency Supply of Schedule 2, 3 and 4 Controlled Drugs   

Pharmacists are not permitted to provide emergency supplies of controlled drugs in schedule 2, 3 or 4 whether at the request of a prescriber or a patient, unless further specific conditions are met in accordance with the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended), including that in the pharmacist’s opinion:  

• there is an immediate need for the supply of the controlled drug to be made,   
• it is safe, appropriate, and necessary to make the supply for the continued treatment of the patient,   
• it is not possible to obtain a prescription without undue delay,   
• the treatment has previously been prescribed for the patient, and   
• no more than 5 days treatment or the nearest equivalent minimum dosage pack unit size is being supplied (additionally, where the supply is in on foot of a request by a patient.)  
• an emergency supply of the controlled drug has not already been supplied based on a request by the patient since their last supply on foot of a prescription.  

Note: Pharmacists can provide an emergency supply of methylphenobarbitone, phenobarbitone, phenobarbitone sodium, midazolam, clobazam, or clonazepam, at the request of either a prescriber or a patient, without having to satisfy the additional conditions above, where it is for the treatment of epilepsy.  

In February 2016, the Regulation of Retail Pharmacy Businesses Regulations were amended (S.I. No. 80 of 2016) to include regulation 5(1) (ea), which puts in place a legal requirement that all pharmacy-only medicines be stored in a part of the pharmacy to which the public does not have access. It states:   
5(1) (ea) medicinal products other than medicinal products referred to in sub-paragraph (e), and not being medicinal products on a general sales list, are stored in a part of the premises to which the public does not have access.   

A Regulatory Notice from the PSI was issued in October 2017, which explains that there are several ways in which pharmacies can comply with the requirements of the legislation including:   

• Storage of pharmacy-only medicines behind the medicines counter/OTC counter.   
• Any other arrangements within the premises that ensures that the public does not have direct or physical access to pharmacy-only medicines.   

When considering whether you have met the requirements of the legislation, you should ask yourself: Is a member of the public able to self-select (i.e. physically access / pick up) a pharmacy-only medicine from a publicly accessible part of the pharmacy?   

The answer to this should be no.   

You can check the ‘latest list of pharmacy only medicinal products not subject to medical prescription’ and ‘latest list of general sales product information’ on the Health Products Regulatory Authority’s website.   

To supply and administer Influenza vaccines, pharmacists must first undertake or have up-to-date training in the following programmes:    

• CPR for adults and children   
• Responding to an Emergency Situation and Management of Anaphylaxis (RESMA)    
• Medicines Administration (Parenteral) (PAMT)    
• Delivery of a Pharmacy-Based Vaccination Service    
• Administration of Influenza Vaccination Training Programme 2023/2024 (Available through the IIOP)   

Information on the training programmes approved by PSI, as well as the providers and how to book these courses is available on the Irish Institute of Pharmacy (IIOP) website. As well as completing the relevant training detailed above, pharmacists must also complete a self-assessment of competence.

• The procedure to be followed following breakdown in the ‘cold chain’ is set out in the HSE Guidelines for maintenance of cold-chain in vaccine fridges and management of vaccine stock. In addition, the following resources may be helpful:   
• Recommendations for maintenance of Vaccine Fridge within Temperature during a Planned Power-cut   
• Vaccine Ordering and Storage   

30-minute e-learning module Storing and Managing Vaccines available on www.hseland.ie   

No. Under Regulation 4B of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) the authority to supply and administer a vaccine in a retail pharmacy business, without a prescription, is solely vested to an appropriately trained registered pharmacist.

Information is provided by the HSE about the National Cold Chain Service.

A pharmacy may highlight the availability of a vaccination service provided by that pharmacy, to their patients and members of the public. This can include the display of factual information in relation to the pharmacy vaccination service. It must not include the brand name of a specific vaccine.   
   
All vaccines are licensed as prescription-only medicines and the advertising of prescription-only medicines to the public is not permitted by the Medicinal Products (Control of Advertising) Regulations 2007. 

Yes. Pharmacies can provide a vaccination service at the registered pharmacy premises, outside of the normal opening hours, provided a registered pharmacist is always present on site. Pharmacy owners and superintendent pharmacists planning a vaccination service outside the normal opening hours of the pharmacy should ensure appropriate security is in place to safeguard their staff members and ensure patients and members of the public do not have access to the dispensary or other areas that medicines are kept. 

If you wish to add a second patient consultation area to your pharmacy floor plan, you can send the PSI a copy of the updated floor plans in advance of commencing any works, outlining the changes that are to be made to the original floor plan. Pharmacies can make certain changes to their registration details using the online registration portal.   
   
We will review these floorplans on a case-by-case basis and advise if it will be necessary to complete a Material Change Form and/or pay an associated fee. However, the need to add an additional consultation area should be considered in light of changes to legislation which allow pharmacists to deliver certain vaccination services (COVID-19 and Influenza vaccines) at locations offsite from the registered pharmacy premises (see below).   

Yes. In October 2020, legislation was amended to permit appropriately trained pharmacists to supply and administer the influenza vaccine at any suitable and appropriate place (i.e., within or offsite from the retail pharmacy business premises) having regard to public convenience and the need to protect the health and safety of the public. This includes the influenza vaccine suspension for injection presented as a pre-filled syringe, and the influenza vaccine nasal spray, suspension.   

Any influenza vaccination service provided offsite under this legislation must be carried out in connection with a named registered retail pharmacy business, in which the vaccinating pharmacist is employed or engaged. The PSI has published guidance to support this practice extension.   

Legislation permits an appropriately trained pharmacist to supply and administer the influenza vaccine suspension for injection presented as a pre-filled syringe and the influenza vaccine nasal spray, suspension, at any suitable and appropriate place (i.e., within or offsite from the retail pharmacy business premises) having regard to public convenience and the need to protect the health and safety of the public.    

Your choice of location should include a risk assessment to assure patient safety and the same high standard of care as would be provided on the pharmacy premises. Whether delivery of an influenza vaccination to a patient in an off-site location is, suitable and appropriate will, depend on several considerations.    

 We have published guidance to help you in considering what types of location are appropriate, and to support pharmacies in providing safe influenza vaccination services offsite from the pharmacy premises. There are a few checklists included in the guidance and key points for consideration. Current PSI guidance which supports the provision of a pharmacy vaccination service in the pharmacy will still apply and must be read and adapted to the chosen setting. 

Patients should have advance notice of the location and nature of the off-site vaccination site. As is the case with all vaccination services, both the patient and pharmacist should be satisfied that the given setting is appropriate for the individual patient.   

No. While legislation has been introduced to enable administration of COVID-19 vaccinations and Influenza vaccinations by students of health professions, including students undertaking a master’s degree in pharmacy, this applies to administration of vaccinations by vaccinators employed by the HSE. These services operate under the management and governance of the HSE.

Yes. The Department of Health has amended the Medicinal Products (Prescription and Control of Supply) Regulations 2003(as amended), to enable the recognition of prescriptions written in the UK by registered medical practitioners, registered dentists and registered nurse prescribers, including midwife prescribers, for dispensing in the State. The Regulations came into effect on 1 January 2021. This is on the provision that the prescription has not been issued with a view to enabling the supply of a medicine by mail order and the prescription has not been issued by means of information society services (Further information can be found below).

The prescription must meet the same legal requirements, as those already in place for a prescription issued by a relevant practitioner practicing in another EEA state.   
   
In accordance with the Code of Conduct for Pharmacists, a pharmacist must always put the patient first and make their health, wellbeing and safety his or her primary focus. As well as the requirements detailed in the legislation, the pharmacist must be satisfied as to the authenticity, content and, more importantly, that it is safe and appropriate to dispense the medicine for the individual patient. If the prescription does not meet the legal requirements or you are not satisfied that the medicine is appropriate for the patient, you should explain this to the patient and refer them to another appropriate healthcare professional or service for further care.   

In addition, please note:    

• The original prescription must be presented in the pharmacy. A fax or scanned copy of a prescription is not a legally valid prescription. Electronic prescriptions are not currently supported by the current legislation in Ireland.   
• Products classified as schedule 2, schedule 3 or schedule 4 part 1 controlled drugs may not be prescribed by practitioners registered in the UK for dispensing in Ireland, and such prescriptions may not be used to authorise the supply of any such controlled drug.   
• The product prescribed must be licensed in Ireland.   

In practice this means that cross-border telemedicine services are prohibited by law. For example, a prescription that comes from an online doctor service where the prescriber is based in the UK will no longer be valid for dispensing in a pharmacy registered in Ireland.   
   
It is up to the pharmacist to use their professional judgement to identify any prescriptions that fall into this category. This could be done, for example, by discussing with the patient the method of consultation, and using the work address, email address and telephone number of the person issuing the prescription (as required for a valid prescription from a doctor registered in the EEA or UK).

No. It is prohibited (as per Regulation 19A(8) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended)) to sell and supply non-prescription medicines at a distance by means of information society services to a member of the public in the UK. This prohibits the sale or supply of non-prescription medicines over the internet from a pharmacy listed on part A of the PSI’s Internet Supply List, or a non-pharmacy listed on Part B of the of the Internet Supply List to a patient/customer in the UK (as is currently the case for supply to a customer in a country outside the EEA).

Yes. Access to cross-border health services are all part of Government contingency planning with the latest information available on Gov.ie.

Brexit has not had any immediate impact on the supply of medicines as there are already additional stocks of medicines routinely built into the Irish medicine supply chain. The Department of Health, together with the HPRA, the HSE and many others, continues working to protect the availability of medicines for Irish patients, acknowledging the extent of medicines moved through the UK to get to Ireland.   

Ireland is unlikely to face general medicine supply issues while normal use of medicines is maintained. The Department of Health has clearly stated that hospitals, pharmacists or patients should not order extra quantities of medicines, and doctors should not issue multiple prescriptions for the same medication. The impact of doing so will have a knock-on effect on managing existing stock levels and hamper the supply of medicines for other patients. All involved must balance the interests of their patients and wider society where challenges may arise. Pharmacists and other health professionals have a significant role to play in providing accurate information to people to avoid disruption and aid understanding of Ireland’s medicines supply arrangements.   

Shortages exist already in the market, without any relation to Brexit. The HPRA’s Medicine Shortages Framework will continue to be used to manage these shortages and seek to reduce the impact on patients and healthcare professionals.   

Access to cross-border health services and validity of UK prescriptions are all part of Government contingency planning with the latest information available on www.gov.ie/Brexit   

• The PSI’s dedicated Brexit webpage will continue to be updated as more information becomes available.   
• The Department of Health has published information for members of the public regarding healthcare and Brexit.   
• The HSE has published information about getting treatment abroad and cross border.   
• The HPRA has a dedicated webpage for information related to Brexit and the health products they regulate.