Emergency life-saving medicines and PHECC’s role in educating the public to administer these medicines
Last October (2015) the previous Minister for Health, Leo Varadkar, signed into legislation Statutory Instrument SI No. 449 of 2015 Medicinal Products (Prescription and Control of Supply (Amendment) (No. 2) Regulations. It is commonly known as SI 449 of 2015 or the emergency medicines legislation. These regulations allow trained non-medical persons to administer six prescription-only medicines to a person, without a prescription, for the purpose of saving their life or reducing severe distress in an emergency situation.
The medications, emergency conditions and the administration route are listed below.
|Epinephrine (adrenaline) (pre-filled syringe)
||Treatment of anaphylactic shock (adults and children)
||Treatment of hypoglycaemia (adults and children)
||Intramuscular or subcutaneous injection
||Treatment of severe angina attack (adults)
|Medical gas mixture of 50% nitrous oxide and 50% oxygen
(Note: the administration of this is restricted to those engaged or employed by an emergency rescue organisation)
|Pain relief in emergency rescue situations (adults and children)
|Treatment of respiratory depression secondary to known or suspected narcotic overdose (adults and children)
||Treatment of acute asthmatic attack (adults and children)
Since this emergency care initiative was introduced PHECC has established a framework for the education and training of lay persons to safely and competently administer these medicines to those urgently requiring care.
The foundation for the framework began with the development of education and training standards overseen by the Education and Standards Committee. The CFR and Medications for Listed Organisations Education and Training Standards
consist of two distinct modules; Medication Management (Module 4) and Medication Administration (Module 5) for each of the six listed medications, and the approval criteria for course instruction. These standards are underpinned by the newly revised Cardiac First Response (CFR) Standards (2016)
, which teach basic emergency care (Module 1), access and use of an automated external defibrillator (Module 2) and safety and communication (Module 3).
Partnering with these new standards are the Clinical Practice Guidelines
for Medication Listed Organisations (2016). The CPGs contain critical information to direct the trained lay person in treating persons with the above emergency conditions. They include guidance on the implementation and use of the CPGs with reference to the medicines regulations and the 3 D’s – Dosage, Definitions and Documentation. An explanatory code pre-empts the individual CPGs for adult and paediatric patients (8 CPGs in total). There is also a detailed medication formulary.
We have developed education and instructor material to support our recognised institutions (RIs) in using the standards and CPGs to deliver the CFR and Medications for Listed Organisations Courses. The materials specific to each of the six medicines include lesson plans, PowerPoint presentations, an overview document for the instructor and course participant, and extensive supplementary reference documents. In offering this standardised instructor pack for the courses PHECC anticipates RIs will be in a position to provide these new courses expediently, utilising a consistent approach to teaching medication management and emergency care to non-medical people. This initiative is new to the Irish pre-hospital emergency care landscape so PHECC is keen to work closely with our RIs to determine the suitability of the instructor pack. PHECC encourages RIs and their instructors’ innovation in course delivery based on the needs and experiences of course participants.
An initial suite of FAQs
has been created to assist you in learning more about the medicines regulations and PHECC’s framework and accompanying structures and processes for the introduction and implementation of SI 449 of 2015. The FAQs section also gives an overview of the other healthcare regulators’ – Health Product Regulatory Authority (HPRA) and the Pharmaceutical Society of Ireland (PSI) involved in the implementation of the emergency medicines legislation. PHECC would like to thank these agencies for their ongoing collaboration on this critical public health project.
This past July saw the start of the application process for RIs and those organisations seeking RI status by PHECC for course approval for the CFR and Medications for Listed Organisations and the Add-on Module for Emergency First Response (EFR). Once RIs receive approval to deliver these courses we regularly update this information on our dedicated webpage listing.
We are committed to monitoring our regulatory responsibilities inclusive of structures, processes and outcomes for the commencement of the emergency medicines legislation, giving authority for trained non-medical persons working or volunteering in a listed organisation to administer the six lifesaving medicines of epinephrine, glucagon, glycerol trinitrate, medical gas mixture of 50% nitrous oxide and 50% oxygen, naloxone and salbutamol for associated emergency conditions.
Please go to the website
for updates about project developments for SI 449 of 2015. If you have questions that are not addressed by our FAQs, please email us at email@example.com
with the subject heading SI 449 of 2015.