FAQs for Cardiac First Response and Medications for Listed Organisations Course(s) in accordance with the emergency medicines legislation (SI 449 of 2015)
Listing of Questions
1.
What is the emergency medicines legislation for non-medical persons?
2.
What are the emergency medicines covered in this new legislation?
3.
What is a listed organisation?
4.
What does it mean to be the accountable person in a listed organisation?
5.
What do I need to do to be able to administer any of these medications?
6.
Where can I access a course?
7.
What can I expect on the Cardiac First Response (CFR) and medications for listed organisation course?
8.
Will I get a certificate?
9.
Who can teach these new courses?
10.
How do I or my organisation become a PHECC Recognised Institution?
11.
How can I obtain these medicines for use in an emergency?
Additional information – an overview of healthcare regulators’ roles for carrying out the emergency medicines legislation (SI 449 of 2015).
What is Pre-Hospital Emergency Care Council’s role?
What is the Health Product Regulatory Authority’s role?
What is the Pharmaceutical Society of Ireland’s role?
1. 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, for the purpose of saving their life or reducing severe distress in an
emergency situation. 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 medical gas mixture 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 provision of 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 completes an approved training course for each of the medicines that 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 which 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 is available to read at
www.irishstatutebook.ie.
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2. What are the emergency medicines covered in this new legislation?
Epinephrine (adrenaline)
(pre-filled syringe)
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Treatment of anaphylactic shock (adults and children)
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Intramuscular injection
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| Glucagon |
Treatment of hypoglycaemia (adults and children)
|
Intramuscular or subcutaneous injection |
Glycerol trinitrate
|
Treatment of severe angina attack (adults) |
Sublingual spray
|
Medical gas mixture of 50% nitrous oxide and 50% oxygen
|
Pain releif in emergency rescue situations (adults and children)
|
Inhalation |
Naloxone hydrochloride
(pre-filled injection)
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Treatment of respiratory depression secondary to known or suspected narcotic overdose (adults and children)
|
Intramuscular injection |
| Salbutamol inhaler |
Treatment of acute asthmatic attack (adults and children) |
Inhalation
|
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3. 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 which 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. When entered onto this list, the organisation is a “listed organisation”.
Under the 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 provision of rescue services to persons who cannot, without specialised assistance, remove themselves from danger or entrapment due to injury, illness or environmental conditions".
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4. What does it mean to be the accountable person in a listed organisation?
A listed organisation must appoint one or more persons, who is 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.
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5. What do I need to do to be able to administer any of these medications?
You must complete a Cardiac First Response (CFR) course in accordance with PHECC current CFR Education and Training Standards. In addition to CFR skills, you will be trained in the administration of the specific medication for the course chosen. You will also be taught how to manage a person in the following circumstances:
a) severe reaction (anaphylaxis) in an out-of-hospital environment,
b) hypoglycaemia,
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 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 that is listed with HPRA.
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6. Where can I access a course(s)?
Only PHECC recognised institutions (RI) approved for each course can deliver this training. Our website will list the RIs that are approved to deliver these courses and training. We regularly update our listing which can be found
here.
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 organisations – for Medical gas mixture of 50% nitrous oxide and 50% oxygen only.
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7. What can I expect on 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 as well as 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.
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8. Will I get a certificate?
Yes, if you are successful in the course you will be issued with 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).
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9. Who can teach these new course(s)?
• Holders of PHECC instructor certificates/awards at the level of Emergency First Response (EFR) instructor, PHECC Educational Award holders at the level of Facilitator/Tutor or Assistant Tutor. It is mandatory that all instructors/PHECC Educational Award holders maintain CFR instructor certification.
• Other registered healthcare professionals with emergency medicine or midwifery experience, and it’s 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 in accordance with the PHECC Medications for Listed Organisations Standard and clinical practice guidelines (CPGs).
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10. How do I or my organisation become a PHECC Recognised institution?
You must apply to PHECC to become a recognised institution.
Organisations seeking to apply for recognition must be able to demonstrate the ability to comply with PHECC’s 31 quality standards (as part of our Quality Review Framework) through their own quality assurance systems. In preparation for applying we advise you to first read:
• Read the
31 quality standards (which are the foundation for the PHECC Quality Review Framework)
• Become familiar with the Council Rules for Recognition of Institution
• Read the Cardiac First Response (CFR) and Medications for Listed Organisations Education and Training Standard 2016. The course approval criteria (pages 29-30) should be reviewed carefully to ensure you can meet them all in full.
You must contact the office to arrange a pre-submission meeting with PHECC officers. At the meeting, you must be able to show evidence of capacity to comply with Council’s quality review framework. Pre-approval site visits may also be arranged.
Full information about applying to become a recognised institution can be accessed
here.
If you have questions relating to the application process please email us at (
info@phecc.ie)
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11. 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 the event of 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 for 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 which include 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 in order to be registered as a listed organisation and obtain the medicines for use in 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 is going to 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 the 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 situation.
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An overview of healthcare regulators’ roles for the implementation of the emergency medicines legislation. PHECC is working with the Department of Health, the Health Product Regulatory Authority (HPRA), and the Pharmaceutical Society of Ireland (PSI) to ensure the safe enactment of this legislation.
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What is Pre-Hospital Emergency Care Council’s role?
The Pre- Hospital Emergency Care Council protects the public by independently specifying, reviewing maintaining and monitoring standards of excellence for the safe provision of quality pre-hospital emergency care.
PHECC has developed education and training standard modules and clinical practice guidelines (CPGs) for carrying out this public health initiative. This includes basic life support and administration and management of the specific emergency medication. PHECC is responsible for approving recognised institutions to deliver and certify courses for lay people/non-medical persons/members of the public. PHECC has devised training instruction materials to aid RIs in their delivery of the courses.
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What is the Health Product Regulatory Authority’s Role?
Health Product Regulatory Authority (HPRA)’s Role www.hpra.ie
The legislation provides for the creation of a list by the HPRA of organisations that may procure one or more of the specified medicines for supply and administration in an emergency situation. The list will be publically available to all interested stakeholders via the HPRA website
HPRA website .
To ensure inclusion on the published list, an organisation must submit a valid ‘notification’ to the HPRA via the Emergency Medicines Portal.
This notification should include confirmation of the appointment of at least one accountable person who is legally responsible to ensure compliance with the legislation. The organisation should also ensure that there are individuals trained in the use of all medicines it wishes to procure, before it notifies HPRA of its intention to procure those medicines.
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What is the Pharmaceutical Society of Ireland’s Role?
Pharmaceutical Society of Ireland (PSI)’s Role www.thepsi.ie
General information on Role of the PSI
The Pharmaceutical Society of Ireland (PSI) protects the health and safety of the public by regulating pharmacists and pharmacies in Ireland.
In the context of SI 449 of 2015 the PSI sets the standards of training for pharmacists to be competent to administer these medicines in an emergency. The PSI has also produced guidance for pharmacists on the supply of emergency medicines to listed organisations for use under this legislation.
Information on supply to Listed Organisations
Currently the PSI website states the following with regard to supply to listed organisations under SI 449.‘Supply of emergency medicines to listed organisations
The legislation also allows organisations that are entered in the ‘listed organisations list’ to get the above medicines from a pharmacy, against a valid signed order, for administration by trained non-medical people in an emergency situation. The list of organisations will be available on the Health Products Regulatory Authority’s (HPRA) website, and pharmacists making a supply will be required to check against it. This list and training for organisations are not yet in place, but we will communicate information relevant to pharmacists once available. ‘ See link
link to webpage.
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