What is the emergency medicines legislation for non-medical persons?
In October 2015, the Minister of Health signed into legislation - Statutory Instrument SI No. 449 of 2015 Medicinal Products (Prescription and Control of Supply (Amendment) (No. 2) Regulations (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, to save their life or reduce severe distress in an emergency.
The emergency medicines are:
• Epinephrine (adrenaline) auto-injector
• Glucagon hydrochloride injection
• Glyceryl trinitrate sublingual spray
• Naloxone hydrochloride pre-filled syringe
• Salbutamol 100mcg multi-dose inhaler
• 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*)
*In the context of these Regulations, an 'emergency rescue organisation' means an organisation whose functions include providing rescue services to persons who cannot, without specialised assistance, remove themselves from danger or entrapment due to injury, illness or environmental conditions.
To ensure that these medicines are administered safely, the legislation requires that the non-medical person complete an approved training course for each of the medicines they wish to administer.
As well as completing an approved training course, the person must be engaged or employed (including in a voluntary capacity) by a listed organisation that may obtain a stock of the specified medicine for supply and administration in the event of an emergency.
The Regulations also require that the listed organisation must appoint an accountable person. This may be a person who has completed the training to administer emergency medicines or another person.
Statutory Instrument SI No. 449 of 2015 Medicinal Products (Prescription and Control of Supply (Amendment) (No. 2) Regulations are available to read at www.irishstatutebook.ie.
What is a listed organisation?
An organisation that wishes to procure one or more of the six emergency medicines must notify the Health Products Regulatory Authority (HPRA) by completing a form that can be accessed at www.hpra.ie. The organisation must notify the HPRA of the address of each premises where the medicines will be stored for use in an emergency. The HPRA will publish a list of organisations that have provided a valid notification on their website. The organisation is a "listed organisation" when entered onto this list.
Under regulations, an organisation can include:
a) An organisation, body, person or group in control of a place of worship, a place of hospitality, an entertainment venue, a place of work, a sports venue, a sports club, a train station, a bus station, a ferry port, an airport or aerodrome, a commercial aircraft, a passenger ferry, a supermarket, a shopping centre, an educational establishment, a childcare facility, a crèche, a museum, an art gallery, an exhibitions centre
b) An Garda Síochána,
c) the Courts Service,
d) a local authority,
e) the Health Service Executive,
f) a fire service,
g) an emergency rescue organisation – defined as: "an organisation whose functions include the provision of rescue services to persons who cannot, without specialised assistance, remove themselves from danger or entrapment due to injury, illness or environmental conditions".
What does it mean to be the accountable person in a listed organisation?
A listed organisation must appoint one or more persons employed or engaged by the listed organisation (including in a voluntary capacity or as a volunteer) to be the accountable person(s). The accountable person is legally responsible for compliance with the Regulations, including the safe storage and use of emergency medicines by persons who have completed the approved training.
The Regulations state that the accountable person must:
• oversee and manage the appropriate storage of a medicine procured by the listed organisation for use in an emergency
• oversee and manage the appropriate conditions for storage of such medicine
• ensure that the medicine is procured from a registered retail pharmacy business or where the medicine is the medical gas mixture of 50% nitrous oxide and 50% oxygen (for example, Entonox) from the holder of a wholesaler's authorisation
• ensure that such medicine is only supplied to a person(s) (who may also be the accountable person) employed by or engaged by the listed organisation for supply and administration in an emergency
• maintain confidential records at the premises of the listed organisation for the procurement and storage of such medicine
• ensure that the person(s) with responsibility for supplying and administering such medicines in an emergency are appropriately trained and that their training certificate is valid
• assist An Gard Síochána or any other investigative body with its investigations in the event of an adverse event or incident relating to the procurement, storage, supply or administration of the medicine.
What do I need to do to be able to administer any of these medications?
You must complete a Cardiac First Response (CFR) course under PHECC current CFR Education and Training Standards. In addition to CFR skills, you will be trained to administer the specific medication for the chosen course. You will also be taught how to manage a person in the following circumstances:
a) severe reaction (anaphylaxis) in an out-of-hospital environment,
c) severe angina attack,
d) respiratory depression secondary to known or suspected narcotic overdose and
e) acute asthmatic attack in an out-of-hospital setting until handover (or referral) to the appropriate practitioner.
* Note: The administration of a medical gas mixture of 50% nitrous oxide and 50% oxygen is directed at those training as Emergency First Responders (EFRs) and who are employed by or volunteering with an emergency rescue organisation listed with HPRA.
Where can I access a course(s)?
Only PHECC recognised institutions (RI) approved for each course could deliver this training. Our website will list the approved RIs to deliver these courses and training. STAC First Aid is a PHECC-recognised institution.
The courses will be available to:
• existing and new CFR responders who wish to avail of PHECC certified additional training in any or all of the 5 medications (adrenaline auto-injector, glucagon hydrochloride injection, glyceryl trinitrate sublingual spray, naloxone hydrochloride pre-filled syringe, salbutamol multi-dose inhaler)
• existing and new EFR responders who are practising on behalf of a listed emergency rescue organisation – for Medical gas mixture of 50% nitrous oxide and 50% oxygen only.
What can I expect from the Cardiac First Response course with one/or more of the medications for listed organisations?
The CFR part of the course uses a video to guide course delivery and instructor and student manuals. This part of the course takes about 4-5 hours. These courses consist of the following modules:
• Module 1 Basic Emergency Care
• Module 2 Access and use of an Automated External Defibrillator
• Module 3 Safety and Communication
• Module 4 Medication Management
• Module 5 Medication Administration
The duration of the Medication Management – Module 4 and Medication Administration Module 5, including assessment, is no less than 2-4 hours. The assessment will be skills-based designed scenarios and multiple-choice questions to support your knowledge and skills learned in the course.
Will I get a certificate?
If you are successful in the course, you will be issued a joint PHECC/Recognised Institution CFR or EFR certificate and named medicinal product cards/certificates as appropriate. The CFR certification lapses after 2 years when a new course must be undertaken.
The EFR certification lapses after 3 years. It is also necessary for you to retain certification in CFR (every 2 years).
Who can teach these new courses?
• Holders of PHECC instructor certificates/awards at the Emergency First Response (EFR) instructor level, PHECC Educational Award holders at the level of Facilitator/Tutor or Assistant Tutor. All instructors/PHECC Educational Award holders must maintain CFR instructor certification.
• Other registered healthcare professionals with emergency medicine or midwifery experience are within their scope of practice, such as doctors, nurses, and midwives. Note - There is no PHECC instructor certificate for this group.
The course director requirement for this course is an experienced EFR instructor or above (assistant tutor, tutor and facilitator). PHECC will consider alternative course directors on a case-by-case basis.
All training courses will be delivered under the PHECC Medications for Listed Organisations Standard and clinical practice guidelines (CPGs).
How can I obtain these medicines for use in an emergency?
A listed organisation can obtain emergency medicines from a pharmacy to hold as stock on their premises for use in an emergency. An order for the medicine must be presented to the pharmacy that has been signed by the accountable person taking responsibility for the medicine.
The legislation does not allow individual persons to obtain these medicines. The Health Product Regulatory Authority (HPRA) is the regulator responsible for establishing and maintaining the list of organisations authorised to obtain these medicines.
SI 449 of 2015 requires the listed organisation to appoint a person or persons employed or engaged by that organisation (including volunteers) to carry out/perform certain responsibilities/functions, including safe management, storage and recording. The person(s) appointed is called the accountable person(s).
The Eleventh Schedule of SI 449 of 2015 details what a listed organisation must provide to HPRA to be registered as a listed organisation and obtain the medicines for emergencies. The details are:
1. Organisation name and address
2. Name of the accountable person(s) appointed
3. Business name or trading style to be used by the organisation where that name is different to the name required above
4. Permanent address of the premises where your organisation is going to store the medicines and from which/where they are to be supplied
5. Starting date for when the listed organisation will be holding the medications for use in emergencies.
6. Name of the medicine(s) the listed organisation wishes to procure/obtain
7. Declaration/statement that the procurement, storage, supply and administration of medication for use in emergencies will be conducted in compliance with SI 449.
The HPRA has an online system for organisations - the Emergency Medicines Portal to notify HPRA of their intention to procure or purchase a specific medicine from a pharmacy or other supplier for supply and administration in the event of an emergency.