The Administration of Injectable Medicines by Pharmacists

Background

Training for the supply and administration of certain vaccinations and emergency medicines

Pharmacists who have completed the required training are permitted, under Regulation 4B and/or 4F of the Medicinal Products (Prescription and Control of Supply) Regulations  2003 (as amended), to supply and administer certain vaccines and emergency medicines listed in the Eighth and Twelfth schedules to the Regulations. These include the influenza vaccine, pneumococcal polysaccharide vaccine, herpes zoster (shingles) vaccine and COVID-19 vaccines. Pharmacists are also authorised to supply and administer adrenaline, salbutamol inhaler, glucagon injection, glyceryl trinitrate aerosol and naloxone, for the purpose of saving a life or reducing severe distress in certain emergency situations. 

Pharmacists who wish to supply and administer these vaccinations and emergency medicines are required to undertake mandatory accredited or approved training to ensure they have the knowledge, skills and competence to safely deliver these services.

Provision of other medicines administration services

In addition to the above, we are aware that certain other medicines are being administered to patients by some pharmacists on foot of prescriptions issued by registered prescribers. 

As part of a regulatory review of the administration of medicines by pharmacists in community pharmacies, the PSI carried out surveys with pharmacists and the public between July and September 2023. The purpose of the surveys was to better understand the range of medicines currently being administered by pharmacists in community pharmacies to help determine if the existing regulatory framework is sufficient to support pharmacists in providing safe, consistent and high-quality medicines administration services to patients and the public.

Regulatory expectations

Pharmacists and those in governance roles in pharmacies have a responsibility to ensure that all pharmacy services provided to patients are safe, appropriate and of a high quality. This includes the provision of services to administer injectable medicines on foot of prescriptions issued by authorised prescribers. 

Governance

Pharmacy owners have overall responsibility for the governance and regulatory compliance of the pharmacy. They have shared responsibility with the superintendent pharmacist and supervising pharmacist for ensuring that appropriate management, leadership, and accountability are established and maintained. They also have a responsibility to support the superintendent pharmacist and supervising pharmacist in discharging their duties. Pharmacy owners should ensure that all services being offered are in accordance with guidelines and premises are set up and maintained appropriately to deliver those services.

In pharmacies that offer additional medicines administration services, there is an expectation that those in governance roles ensure all pharmacists administering medicines are appropriately trained and competent to do so. 

The PSI has published Guidance on Pharmacy Governance Roles which details the responsibilities of pharmacy owners, superintendent pharmacists and supervising pharmacists. 

Code of Conduct

It is important to note that all pharmacists must adhere to their Code of Conduct in all services they offer. Pharmacists should use their professional judgement and ensure they are clinically competent to deliver the service being offered. Pharmacists should also ensure they are putting patient safety at the centre of every service they offer. 

Any medicines being administered by pharmacists should be legally prescribed to the patient by an appropriately authorised prescriber before being administered, except for those medicines and emergency medicines specified in the Regulations which may be supplied and administered by pharmacists as set out above.

Patient Assessment and Consent

Pharmacists should perform a clinical check on every prescription to ensure the medication is therapeutically appropriate for the patient. They must also counsel the patient to ensure they understand the medicine's purpose, possible side effects, and any other relevant clinical information. This counselling allows patients to make informed decisions and give their consent before receiving the medicine.  It may also be appropriate to record consent from the patient, depending on the nature of the service.  As per the Code of Conduct, pharmacists “must adhere to the principles of consent, complying with all statutory provisions in this regard”.

Pharmacists may refer to the PSI’s Ethical Decision making framework to assist in decision making if they are considering offering any new service.   The HSE National Consent Policy may also be a useful source of information.

Training

Pharmacists who intend to offer a medicines administration service should first assess their competence in the administration of injectable medicines.   It may be necessary to undertake training, such as the training provided for pharmacists providing vaccination services or administering emergency medicines. You can find out more about these training requirements. 

Pharmacists should be competent and confident in dealing with adverse reactions and emergency situations that may arise following the administration of injectable medicines, including anaphylaxis.

Pharmacists should also ensure that they review the Summary of Product Characteristics (SPC) of each specific medicinal product being administered and be up to date with any relevant national guidelines (e.g., from the National Immunisation Advisory Committee).  Other training may also be required to be developed and undertaken as deemed necessary and appropriate.

Indemnity arrangements

Pharmacists should ensure that they have appropriate indemnity insurance to cover the administration of medicines and the offering of such services. Pharmacy owners should also ensure the premises has the appropriate insurance cover for these services.