Guidance on Safe Supply of Medicines

Pharmacists have a professional and legal responsibility to ensure that prescription-only medicines and non-prescription medicines are supplied safely to patients and members of the public, with sufficient information for their appropriate and rational use.

As a medicines expert, the pharmacist has a unique opportunity and duty to discharge this responsibility in their care of patients.

This section contains guidance to assist pharmacists in fulfilling their legal and professional obligations; it highlights the relevant legislation that must be complied with, as well as good practice requirements, to help ensure that medicines are supplied safely.

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Codeine
- Guidance for Pharmacists on the Safe Supply to Patients of Non-Prescription Medicinal Products containing Codeine (Version 5, October 2019)
This guidance sets out the criteria to be adhered to by pharmacists, with a view to ensuring the safe supply of non-prescription codeine medicines to patients. The guidance also deals with the situation where a pharmacist suspects that a patient is abusing and/or misusing these products. The HSE Helpline, freephone 1800 459459 provides a confidential support and information service to people seeking information or assistance with problems related to drug misues, and also maintains a nationwide database of services.
Domperidone
- Guidance on the Safe Supply of Non-Prescription Medicines containing Domperidone (Version 2, Oct 2014)
This guidance details the changes to the licensed indications and contra-indications of domperidone-containing products in Ireland, which resulted from the European Medicines Agency (EMA) evaluation of the benefits and risks of domperidone, published in April 2014. The guidance highlights key responsibilities for pharmacists in the safe supply of these products and the additional monitoring of the use of domperidone as indicated by the inverted black triangle displayed on the package leaflets and summaries of product characteristics (SmPCs) of relevant products, to allow continued assessment of the benefit/risk balance of this medicine.
Dovonex® Psoriasis Ointment
- Guidance on the Safe Supply of Dovonex® Psoriasis Ointment by Pharmacists (Version 1, June 2016)
This guidance assists pharmacists in the safe supply of this product without a prescription for pre-diagnosed plaque psoriasis in adults. It also provides guidance on counselling requirements to help ensure the safe use of this product by the patient. A training deck on this product for pharmacists is available on request by email to LEO Pharma medical information.
High Tech Scheme
- Good Dispensing Practice: High Tech Scheme (Version 2, Jan 2015)
This guidance outlines how the High Tech Scheme operates and highlights the importance of the pharmacist keeping their knowledge up-to-date on all products that they dispense, so that appropriate care can be provided to patients receiving these medicines.
Levonorgestrel
- Guidance for Pharmacists on Safe Supply of Non-Prescription Levonorgestrel 1500mcg for Emergency Hormonal Contraception (Version 6, October 2019)
This guidance outlines clinical considerations that a pharmacist must take into account when supplying this medicine without a prescription for emergency hormonal contraception. It also includes information and advice that should be given to the patient if a supply is appropriate, as well as guidance on when it is necessary to refer the patient to another healthcare professional, service or organisation.

In July 2014, the HPRA issued Emergency Contraception - New information on levonogestrel (Levonelle, Norlevo, Tyedra, Levonogestrel Teva) and ulipristal (ellaOne), which highlights the outcome of a review by the European Medicines Agency which concluded that levonogestrel and ulipristal are suitable emergency contraceptives for all women, irrespective of body weight.

In 2016, the European Medicines Agency completed a review of levonorgestrel 1500mcg tablets and the effect of liver enzyme inducers (some medicines used to treat epilepsy, tuberculosis, HIV, fungal infections and herbal remedies containing St John’s Wort) on the efficacy of hormonal contraception. The review provided new recommendations for woman seeking emergency contraception who have used liver enzyme inducers in the preceding 4 weeks. The PSI Guidance has been updated in light of these new recommendations; the updated sections of the guidance are highlighted in grey (Version 4, December 2016). Please see our Practice Updates for additional information.
Ulipristal Acetate
- Guidance for Pharmacists on the Safe Supply of non-Prescription Ulipristal Acetate 30mg (ellaOne®) for Emergency Hormonal Contraception (Version 3, October 2019)
This guidance outlines clinical considerations that pharmacist must take into account when supplying this medicine without a prescription for emergency hormonal contraception. It provides guidance on the information and advice that should be given to the patient if a supply is appropriate, as well as guidance on when it is necessary to refer the patient to another healthcare professional, service or organisation.
Methadone
- Guidance for Pharmacists on the Safe Supply of Methadone
This guidance highlights what the superintendent pharmacist and supervising pharmacist must do before initiating a methadone service. It includes the requirements for storage and supply of methadone as well as prescription requirements. It also gives guidance on supply of methadone, other than for opioid dependence.
- Inspectors' Advice on Balance Checks and Reconciliation in relation to Methadone Products
Methotrexate
- Guidance to Pharmacists on the Safe Supply of Oral Methotrexate (Version 2, Jan 2015)
This guidance highlights the need for extra vigilance when dispensing methotrexate to patients; a complete review of the patient's previous dispensed medication history is needed each time this medicine is dispensed. Guidance is provided for safely dispensing and labelling methotrexate to minimise the risk of errors, as well as possible signs of methotrexate toxicity warranting immediate reporting and referral.
Sumatriptin

Guidance for Pharmacists on the Safe Supply of Sumatriptan 50mg Tablets (Version 1, October 2018)

This guidance assists pharmacists in the safe supply of Sumatriptan 50mg tablets, in line with the product’s marketing authorisation. Due to the need to confirm the patient’s diagnosis of migraine and the counselling requirements for the appropriate use of this product, Sumatriptan 50mg tablets must only be supplied by the pharmacist.

Safe Prescribing and Dispensing of Controlled Drugs

Safe Prescribing and Dispensing of Controlled Drugs - Joint guidance issued by the PSI and the Medical Council for pharmacists and doctors, incorporating changes made under the Misuse of Drugs Regulations 2017
Controlled Drug Prescription Requirements download this PDF to print this useful table or view the image below with summary of the Controlled Drug Prescription Requirements, as available in the joint guidance.

TABLE 1 – Requirements for Paper and Healthmail Prescriptions for CD2, CD3 and CD4 part 1
Legal requirements	Schedule 2 and 3*	Schedule 4 part 1
Must be written in ink/indelible	Paper: Yes (addressograph sticker not acceptable) Healthmail: Can be issued electronically via Healthmail. Pharmacy must print a copy.	Paper: Yes (addressograph sticker not acceptable) Healthmail: Can be issued electronically via Healthmail. Pharmacy must print a copy.
Include Full Name (including first name) of practitioner	Yes	Yes
Include Practitioner’s Registration Type and Number	Yes	Yes
State the Date of issue	Yes	Yes
Must be dispensed within 14 days of date of issue	Yes	No
Cannot be dispensed before date of issue stated on prescription	Yes	Yes
Must be signed by the prescriber in his/hers usual signature	Paper: Yes Healthmail: Not necessary	Paper: Yes Healthmail: Not necessary
State the Address of Practitioner	Yes, except for Health prescriptions	Yes, except for Health prescriptions
Practitioner must be registered in Ireland within the state	Yes	Yes
Must include Practitioner’s Telephone number	Yes	Yes
Must include Name (including first name) and address of the patient	Paper: Yes, and must be handwritten Healthmail: Yes, but does not need to be hadnwritten	Yes
Must state the name of controlled drug	Paper: Yes, and must be handwritten Healthmail: Yes, but does not need to be hadnwritten	Yes, but does not need to be handwritten
Must state the dose, form, and strength of controlled drug	Paper: Yes, and must be handwritten Healthmail: Yes, but does not need to be hadnwritten	Yes, but does not need to be handwritten
Must state Total Quantity in words and figures	Paper: Yes, and must be handwritten Healthmail: Yes, but does not need to be hadnwritten	Yes, but does not need to be handwritten
Repeats allowed	No	Yes
Emergency supply permitted	Yes	Yes

Viagra CONNECT®
- Guidance for Pharmacists on the Safe Supply of Non-Prescription Sildenafil 50mg film-coated tablets (Viagra CONNECT®)
This guidance assists pharmacists in the safe supply of Viagra CONNECT®, in line with the product’s marketing authorisation. Viagra CONNECT® 50mg Film-Coated Tablets are licensed as a pharmacy-only medicine for the treatment of men aged 18 years and over, for the management of erectile dysfunction.
Other Resources
As well as the guidance listed above, the PSI has issued the following guidance and resources for the safe supply of medicines.

Controlled Drugs
- Information on record keeping and legal requirements for controlled drugs
- Substitution of medicines not included in the HPRA (IMB) List of Interchangeable Medicines
Medicines authorised in Ireland by the Health Products Regulatory Authority (HPRA) and medicines centrally authorised by the European Medicines Agency are easily searchable on the HPRA website. This is an up-to-date reference listing of medicines that includes all prescription and over-the-counter medicines whether they are original brand-name medicines or generic versions along with their classifications, summary of product characteristics document, and in many cases providing access to the package leaflet for patient information purposes.