Public consultation
Access to
adrenaline, glyceryl trinitrate, salbutamol, glucagon, and naloxone to
save life and reduce severe distress
in emergency situations
1.
Introduction:
The Minister for Health, Leo Varadkar TD is seeking views on the existing legal arrangements on the
supply and administration of certain prescription-only medicines used in emergency situations and
to determine whether changes to these arrangements would benefit public health.
This consultation aims to explore the feasibility of setting up a system to allow appropriately trained
non-medical persons to have more ready access to certain prescription-only medicines for use in
emergency situations, while at the same time ensuring that such medicines continue to be
controlled in an appropriate manner in order to reduce the potential risk of their improper use,
which could result in harm to the health of the patient.
The medicines in question are:
o Adrenaline auto-injectors (treatment of anaphylaxis)
o Salbutamol inhalers (treatment of airway obstruction due to asthma or chronic obstructive
airway disease (COPD))
o Glucagon injection (treatment of severe hypoglycaemia (low blood sugar) which may occur in
diabetes)
o Naloxone (treatment used to rapidly reverse the harmful effects of opioids such as heroin,
methadone and morphine)
o Glyceryl trinitrate sublingual spray (treatment of angina)
In addition, views are sought on measures to improve public awareness and patient education about
potentially life-threatening medical conditions.
1
2.
Who can respond to this consultation?
Everyone is welcome to respond. We hope to hear from members of the public, patients, patients’
representative groups, carers, voluntary organisations, healthcare providers, healthcare
professionals, healthcare professionals’ representative bodies and regulators.
3.
Closing date:
This consultation will be available on the Department of Health website from 20/02/2015.
Responses to the questionnaires are invited from all interested parties to arrive not later than
13/03/2015.
4.
How to respond:
There are five prescription-only medicines under review in this consultation. The box on the left of
this webpage contains five links, one for each of the medicines under review. Clink on the link to the
medicines you are interested in, download the word document, complete the questions, save your
responses and email to Medicines_Consultation@health.gov.ie
You may wish to submit responses on some or all of the prescription-only medicines. It is not
necessary to complete all five questionnaires.
If you wish to send additional information as a supplement to/instead of the questionnaire, you may
do so by emailing the information to Medicines_Consultation@health.gov.ie
5.
Background to the current legal provisions regarding supply and administration of
prescription-only medicines:
Many medicines carry a greater risk to public health if they are not used, stored or disposed of
correctly. In many cases these medicines are only available on prescription because of strict
requirements for their safe use. Special precautions apply to the storage of medicines to help ensure
they are fit for use when needed. All medicines must be disposed of in a safe and secure manner.
Injectable medicines carry an additional risk due to the potential for needle stick injury and the
spread of blood borne viruses, therefore particular care should be paid to their safe disposal.
Normal supply and administration arrangements
Under the Medicinal Products (Prescription and Control of Supply) Regulations, 2003 (as amended),
(hereinafter referred to as the “Prescription Regulations”), the supply and administration of
prescription-only medicines is restricted. Prescription-only-medicines are ordinarily supplied on foot
of a valid prescription for a named person. They may only be administered by an authorised
2
Healthcare Professional or in accordance with their directions e.g. self-administered or administered
by a family member or carer in accordance with the directions of the prescription.
Emergency supply and administration - without a prescription
The Prescription Regulations permit advanced paramedics, paramedics and emergency medical
technicians to supply certain prescription-only medicines without a prescription in emergency
circumstances, in the course of their duties, and to administer these at the time of an emergency for
the purpose of saving a life or to reduce severe distress.
The Prescription Regulations permit pharmacists to supply prescription-only medicines, without a
prescription, to patients in emergency situations. In such cases, the pharmacist must interview the
patient and satisfy him/herself that there is an immediate need for the medicine, that it is not
practicable for the patient to obtain a prescription without undue delay, that the medicine has been
prescribed for the patient on a previous occasion, that the pharmacist can ascertain safely the
appropriate dose of the medicine for that patient. In addition a pharmacist may not supply a
medicine that is a controlled drug listed in Schedule 1- 4 of the Misuse of Drugs Regulations, 1988,
(with certain specific exceptions).
However, the Prescription Regulations do not permit a non-medical person, for example a member
of the general public / carers / teachers to obtain a prescription-only medicine for use in an
emergency situation without a prescription for the named patient.
6.
Existing arrangements under review in this consultation:
Legislation
The Minister is considering whether there would be a benefit to public health to making any or all of
the medicines listed in 1 above more widely/readily available for use in emergency situations , in a
safe manner, that could benefit patients/public health and if so, how this should be achieved.
This consultation will explore, in particular, whether there is a benefit to public health in setting up a
system which would allow appropriately trained non-medical persons, such as carers, teachers, etc.
to have greater access to certain prescription-only medicines for use in emergency situations, while
at the same time ensuring that these medicines continue to be controlled in an appropriate manner
in order to reduce potential risks associated with their improper use.
It is not proposed that prescription-only medicines would be ordinarily available without a
prescription. Each of the medical conditions mentioned in this consultation requires appropriate and
regular medical supervision.
Raising awareness
3
Other considerations that will form part of this consultation include measures to improve public
awareness and patient education about potentially life-threatening medical conditions. Such
measures include:



7.
public awareness and education programmes,
promoting the uptake of first aid training courses so that more people are equipped to recognise
a medical emergency and understand the necessary course of action to take,
improving existing clinical guidelines in the treatment and care planning for patients at risk of
experiencing a life threatening medical emergency.
Cost implications:
If the Prescription Regulations are changed following this consultation there will be additional costs
involved. Expected costs include: the cost of each medicine (multiplied by number of distribution
points); the frequency of replacing medicines that have expired; training costs for persons permitted
to administer the medicines; public awareness campaign costs.
8.
What are the ethical and legal implications?
As with any public health intervention, there are ethical and legal issues to be considered with
regard to the supply and administration of medicines in emergency situations. These include the
issue of informed consent since the patient may be unconscious or lack awareness at the time of the
medical emergency. If the patient’s wishes are not evident, it would generally be considered
reasonable for a rescuer or bystander to intervene to treat the patient on the basis of implied
consent and the doctrine of necessity. There is no statutory obligation imposed on any person to
administer treatment in an emergency situation, but if they do so, the Civil Law (Miscellaneous
Provisions) Act 2011 provides that a Good Samaritan who intervenes to provide assistance, including
resuscitation, will not be liable in negligence for any act done in an emergency unless it was done in
bad faith or with gross negligence. The exemption from liability in the 2011 Act does not apply
where the person owes a duty of care to assist the patient, for example, in the context of a doctorpatient relationship.
9.
Freedom of information:
The Department of Health, like all Government Departments, is subject to the Freedom of
Information Act 2014. You should be aware that any information you provide in your replies to this
public consultation may be made available to citizens upon request.
4
(I)
Adrenaline Auto-Injectors - used to treat anaphylaxis
What is anaphylaxis?
Anaphylaxis is a severe, potentially life-threatening, allergic reaction that can affect many of the
systems of the body, including: airways, breathing and blood circulation.
Anaphylaxis is uncommon. It is estimated that only 1 in 1,300 people will develop the symptoms of
anaphylaxis at some point during their life. Anaphylaxis affects people of all ages, but is slightly more
common in females than males. Central Statistics Office (CSO) figures for the years 2007 to 2013
show that a total of 4 people have died in Ireland from anaphylaxis during this period. (Data from
the CSO for 2013 is provisional. Data for 2014 is not yet available from the CSO).
Current arrangements for treating persons at risk of anaphylaxis:
A person at risk of anaphylaxis may be given a prescription for an adrenaline auto-injector(s) (also
known as epinephrine). They are advised to carry the injector with them at all times and ensure they
know how to use it in the event of suffering a reaction. If they are a young person their parents are
advised to carry the auto-injector for them. If the person suffers a reaction, they may be able to
inject themselves or they may require help to do so. An adrenaline injection must be given as soon
as a serious reaction is suspected.
Risks associated with misdiagnosis of anaphylaxis and inappropriate administration of adrenaline:
Incorrect administration of adrenaline to persons with underlying cardiac arrhythmias,
cardiovascular disease including angina and hypertension could result in an exacerbation of these
conditions or significantly worsen health care outcomes for the person.
Adrenaline auto-injectors authorised for use in Ireland
There are three types of adrenaline auto-injectors authorised for use in Ireland:
o EpiPen: a needle releases adrenaline when it is jabbed against the outer thigh
o Anapen: the syringe must be held against the outer thigh and the button of the auto-injector
pressed, this plunges the adrenalin-loaded needle into the muscle
o Jext: should be pushed firmly against the outer portion of the thigh into the largest part of the
thigh muscle.
The duration of shelf life for these medicines is between 18 and 24 months. It is important to note
that auto-injectors with the longest possible shelf-life can prove difficult to obtain and will often only
be available with shorter expiry dates, e.g. 12 months. There will be a financial impact attached to
the need to regularly replace auto-injectors that have expired before being used.
In the following questions you will be asked to consider whether or not there would be benefit to
public health by making adrenaline auto-injectors available without a prescription to appropriately
trained non-medical persons for use in a medical emergency where there is an immediate risk to life.
You are also asked if you consider alternative or additional measures are needed, such as improved
5
public awareness about how to recognise the signs and symptoms of an anaphylactic reaction and
what to do when this medical emergency happens.
Read more about the symptoms, causes, diagnosis, treatment and prevention of anaphylaxis here
http://www.hse.ie/eng/health/az/A/Anaphylaxis/Symptoms-of-anaphylaxis.html
QUESTIONS
Q1.
Please indicate in what capacity you are responding to this questionnaire








Q2.
(i)
(ii)







registered health professional
carer
patient organisation
family
patient
teacher
member of general public
other (please specify)
Have you or a member of your family or a person under your care ever needed to use this
medicine in an emergency?
Yes

No

If so, did you experience any difficulty in obtaining it?
Yes

No

If you answered yes please provide details of the difficulties you experienced:
6
Q3.
(i)
Do you think the current arrangements for supply and administration of adrenaline autoinjectors are adequate?
Yes

No

(ii)
If No, in what way are they inadequate?
Q4.
Do you think non-healthcare professionals, for example carers and teachers who have
undertaken the appropriate level of training and whose organisation has been appropriately
certified , should be permitted to administer adrenaline auto-injectors in emergency
situations?
Q5.
Yes

No

Please tick the option you agree/disagree with from the following statements
(i)
Adrenaline auto-injectors should be made more widely available to non-healthcare
persons for use in emergency situations
(ii)
Agree

Disagree

Adrenaline auto-injectors should be available in
•
Schools and colleges

•
Crèches and playschools

•
Restaurants

•
Sports Centres

•
Other, please specify
7
Q6.
What do you think would be the main benefits to having wider access to adrenaline autoinjectors for administration in emergency situations by appropriately trained non-medical
persons who have been authorised to do so by an approved body / organisation?
Q7.
What do you think are the main disadvantages and / or safety concerns to widening the
availability of adrenaline auto-injectors for administration by appropriately trained nonmedical persons in emergency situations?
Q8.
Do you think medical identification bracelets/cards would benefit persons at risk of
anaphylaxis in the event of an attack?
Q9.
Q10.
Yes

No

In your opinion is there sufficient information available for patients about this potentially life
threatening medical condition?
Yes

No

In your opinion is there sufficient information available for the general public about this
potentially life threatening medical condition?
Yes

No

8
(II)
Salbutamol inhaler - used in the treatment of an asthma attack
Asthma is commonly a long-term condition that can cause cough, wheezing and breathlessness. The
severity of the symptoms varies from person to person. Asthma can be well-controlled in most
people most of the time. A severe onset of the above mentioned symptoms is known as an asthma
attack or an 'acute asthmatic exacerbation'. Asthma attacks may require hospital treatment and can
sometimes be life-threatening, although this is rare.
A salbutamol inhaler is a reliever medicine taken to relieve asthma symptoms quickly. It works by
relaxing the muscles surrounding the narrowed airways. This allows the airways to open wider,
making it easier to breathe again. Salbutamol is generally a safe medicine with few side effects,
unless it is over used. In Ireland it is estimated that 470,000 people have asthma, affecting both men
and women. Central Statistics Office figures for the years 2007 to 2013 show that a total of 359
people have died in Ireland during this period after suffering an acute asthma attack. (Data from the
CSO for 2013 is provisional. Data for 2014 is not yet available from the CSO).
Current arrangements:
Persons diagnosed with asthma and at risk of suffering an asthma attack may be prescribed a
salbutamol inhaler. They are advised to carry their salbutamol inhaler at all times and to ensure they
know how to use it in the event of suffering an attack. In the case of a young person their
parents/guardians are advised to carry the asthma inhaler for them.
Risks associated with misdiagnosis of an asthma attack and inappropriate administration of
salbutamol:
Diagnosis of an asthma attack is best made by an appropriately trained person. Careful attention
should be paid to the assessment of symptoms such as shortness of breath and chest pain, as they
may be of either respiratory (lung) or cardiac (heart) origin.
Read more about the symptoms, causes, diagnosis, treatment, living with asthma and complications of asthma here
http://www.hse.ie/eng/health/az/A/Asthma/
QUESTIONS
Q1.
Please indicate in what capacity you are responding to this questionnaire












registered health professional
carer
patient organisation
family
patient
teacher
9


Q2.
(i)
(ii)

member of general public
other (please specify)
Have you or a member of your family or a person under your care ever needed to use this
medicine in an emergency?
Yes

No

If so, did you experience any difficulty in obtaining it?
Yes

No

If you answered yes please provide details of the difficulties you experienced:
Q3.
(i)
Do you think the current arrangements for supply and administration of salbutamol inhalers
are adequate?
Yes

No

(ii)
If No, in what way are they inadequate?
Q4.
Do you think non-healthcare professionals, for example carers and teachers who have
undertaken appropriate training and whose organisation have been appropriately certified,
should be permitted to supply and administer salbutamol inhalers?
10
Yes

No

Q5.
Please tick the option you agree/disagree with from the following statements
(i)
Salbutamol inhalers should be made more widely available to non-healthcare persons for
use in emergency situations
(ii)
Agree

Disagree

Salbutamol inhalers auto-injectors should be available in the following settings
•
Schools and colleges

•
Crèches and playschools

•
Sports Centres

•
Other, please specify
Q6.
What do you think would be the main benefits to having wider access to salbutamol inhalers
for administration in emergency situations by appropriately trained non-medical persons
who have been authorised by an approved body / organisation?
Q7.
What do you think are the main disadvantages and / or safety concerns to widening the
availability of salbutamol inhalers for administration by appropriately trained non-medical
persons in emergency situations?
11
Q8.
Q9.
Q10.
Do you think medical identification bracelets / cards would benefit persons at risk of asthma
attack?
Yes

No

In your opinion is there sufficient information available for patients about this potentially life
threatening medical condition?
Yes

No

In your opinion is there sufficient information available for the general public about this
potentially life threatening medical condition?
Yes

No

12
(III)
Glucagon injection - used as part of the treatment of a hypoglycaemic episode
Hypoglycaemia, or a "hypo", is an abnormally low level of sugar (glucose) in the blood.
Hypoglycaemia is most commonly associated with insulin-dependent diabetes and mainly occurs if
someone with diabetes takes too much insulin, misses a meal or exercises too hard. People who do
not have diabetes can also experience hypoglycaemia, although this is much rarer. It can be
triggered by malnutrition, binge drinking or certain conditions, such as Addison's disease. Central
Statistics Office figures for the years 2007 to 2013 show that a total of 17 people have died in Ireland
during this period after suffering a hypoglycaemic episode. (Data from the CSO for 2013 is
provisional. Data for 2014 is not yet available from the CSO).
The immediate treatment for a “hypo” is to have food or drink that contains sugar (such as a glass of
lucozade/cola, fruit juice, or 4 to 5 dextrose or boiled sweets) in order to raise the level of sugar in
the blood. If hypoglycaemia is not treated, it may lead to unconsciousness and death because there
is not enough glucose for normal brain function. A Glucagon injection is used to treat severe
hypoglycaemia where oral administration of glucose has failed or is not possible, in order to quickly
raise blood glucose levels and restore consciousness.
Current arrangements:
If a person is at risk of a hypoglycaemic episode they may be given a prescription from their doctor
for a glucagon injection. They are advised to have the glucagon injection available and ensure they
know how to use it in the event of suffering an episode. If they are a young person their
parents/guardians are advised to keep the glucagon injection for them.
Risks associated with misdiagnosis of hypoglycaemia and inappropriate administration of glucagon:
glucagon must not be given to people who are allergic to it. Glucagon should be administered
cautiously to patients with a history of insulinoma (tumour of the pancreas), pheochromocytoma
(tumour of the adrenal gland), or both. In the case of people with certain endocrine disorders
administration of glucagon may result in a sudden and marked increase in blood pressure.
Read more about the symptoms, causes, diagnosis, treatment and prevention of anaphylaxis here
http://www.hse.ie/portal/eng/health/az/H/Hypoglycaemia/)
QUESTIONS
Q1.
Please indicate in what capacity you are responding to this questionnaire




registered health professional
carer
13






Q2.
(i)
(ii)





patient organisation
family
patient
teacher
member of general public
other (please specify)
Have you or a member of your family or a person under your care ever needed to use this
medicine in an emergency?
Yes

No

If so, did you experience any difficulty in obtaining it?
Yes

No

If you answered yes please provide details of the difficulties you experienced:
Q3.
(i)
(ii)
Do you think the current arrangements for supply and administration of glucagon injections
are adequate?
Yes

No

If No, in what way are they inadequate?
14
Q4.
Do you think non-healthcare professionals, for example carers and teachers who have
undertaken appropriate training and whose organisation have been appropriately certified,
should be permitted to supply and administer glucagon injection?
Q5.
Yes

No

Please tick the option you agree/disagree with from the following statements
(i)
Glucagon injection should be made more widely available to non-healthcare persons for
use in emergency situations?
(ii)
Agree

Disagree

Glucagon injection should be available in the following settings
•
Schools and colleges

•
Sports Centres

•
Workplace

•
Other, please specify
Q6.
What do you think would be the main benefits to having wider access to glucagon injection
for administration in emergency situations by appropriately trained non-medical persons
who have been authorised by an approved body / organisation?
Q7.
What do you think are the main disadvantages and / or safety concerns to widening the
availability of glucagon injection for administration by appropriately trained non-medical
persons in emergency situations?
15
Q8.
Q9.
Q10.
Do you think medical identification bracelets / cards would benefit persons at risk of a
severe hypoglycaemic episode?
Yes

No

In your opinion is there sufficient information available for patients about this potentially life
threatening medical condition?
Yes

No

In your opinion is there sufficient information available for the general public about this
potentially life threatening medical condition?
Yes

No

16
(IV)
Naloxone Injection - used to treat opioid overdose
Naloxone belongs to a group of medicines called “opioid antagonists.” In Ireland naloxone is given by
injection to counteract and reverse the harmful effects of opioids. It is used to restore the body’s
breathing if it has been affected by opioids such as heroin, methadone, oxycodone, fentanyl,
buprenorphine, and morphine, for example after an overdose of these drugs, or when an overdose
of opioids is suspected.
Current arrangements:
As naloxone is used only in medical emergencies, the medicine is given by a doctor, paramedic or
nurse.
Central Statistics Office figures for the year’s 2007 to 2013 show that a total of 987 people have died
in Ireland during this period from narcotic overdose. (Data from the CSO for 2013 is provisional. Data
for 2014 is not yet available from the CSO).
The HSE has undertaken to develop and roll out a demonstration of the use of naloxone under the
current legislative framework in 2015. This is to facilitate the wider acceptance of the product and
its wider availability for the prevention of accidental opioid overdose.
Risks associated with misdiagnosis of opioid overdose and the inappropriate administration of
naloxone:
Naloxone must not be given to people with a known allergy to it. Naloxone must be given with
caution to patients who have received high doses of opioids or are physically dependent on opioids.
Too rapid reversal of the opioid effect can cause an acute withdrawal syndrome in such patients.
Other side effects that have been reported include hypertension (high blood pressure), cardiac
arrhythmias, pulmonary oedema (fluid in the lungs) and cardiac arrest.
The following questionnaire applies to naloxone for the treatment of opioid overdose.
QUESTIONS
Q1.
Please indicate in what capacity you are responding to this questionnaire












registered health professional
carer
patient organisation
family
patient
teacher
17


Q2.
(i)
(ii)

member of general public
other (please specify)
Have you or a member of your family or a person under your care ever needed to use
naloxone in an emergency?
Yes

No

If so, did you experience any difficulty in obtaining it?
Yes

No

If you answered yes please provide details of the difficulties you experienced:
Q3.
(i)
Do you think the current arrangements for supply and administration of naloxone are
adequate?
Yes

No

(ii)
If No, in what way are they inadequate?
Q4.
Do you think non health professionals, for example social care workers, family members,
friends, carers or partners of people who use drugs who undertake appropriate training,
should be permitted to administer naloxone?
18
Q5.
Yes

No

Please tick the option you agree/disagree with from the following statements
(i)
Naloxone injections should be made more widely available to non-healthcare persons
for use in emergency situations
(ii)
Agree

Disagree

Naloxone injections should be available in
•
Drug Treatment Service Clinics

•
Needle exchange sites

•
Friends, family members, partners of drug users

•
Other, please specify
Q6.
What do you think would be the main benefits to having wider access to naloxone for
administration in emergency situations by appropriately trained non-medical persons who
have been authorised by an approved body / organisation?
Q7.
What do you think are the main disadvantages and / or safety concerns to widening the
availability of naloxone for administration by appropriately trained non-medical persons in
emergency situations?
19
Q8.
Q9.
In your opinion is there sufficient information available for drug users, family members and
partners of drug users about opioid overdose?
Yes

No

In your opinion is there sufficient information available for the general public about opioid
overdose?
Yes

No

20
(V)
Glyceryl trinitrate sublingual spray - used in the treatment of cardiac chest pain (angina)
Chest pain can be a symptom of many conditions including a heart attack. Glyceryl trinitrate (GTN) is
a medicine that is widely used to provide immediate relief from the symptoms of cardiac chest pain
caused by angina or other cardiac problems. GTN belongs to a group of medicines known as nitrates.
Nitrates work by relaxing and widening the blood vessels that increase the blood supply to the heart.
Ideally GTN should be administered to a person in the sitting or lying position due to the common
side effects of syncope (fainting) or dizziness which it can cause.
Current arrangements:
If a person has been diagnosed with stable angina, they may be given a prescription from their
doctor for glyceryl trinitrate, as part of their treatment plan. They are advised to carry it with them
and ensure they know how to use it in the event of suffering an attack.
Risks associated with misdiagnosis of suspected heart attack and inappropriate administration of
glyceryl trinitrate:
GTN should not be administered to people who are allergic to nitrates, those with a very low blood
pressure, those who have had a brain haemorrhage or brain trauma. It should not be administered
to people on certain medicines to treat, for example, conditions such as high blood pressure or
depression, as it further decreases blood pressure in these situations, which may result in collapse.
Read more about the symptoms, knowing when to get help, recognising a heart attack, causes of chest pain, and risk
factors for heart disease here http://www.hse.ie/eng/health/az/C/Chest-pain/)
Questions
Q1.
Please indicate in what capacity you are responding to this questionnaire















registered health professional
carer
patient organisation
family
patient
teacher
member of general public
other (please specify)
21
Q2.
(i)
(ii)
Have you or a member of your family or a person under your care ever needed to use this
medicine in an emergency?
Yes

No

If so, did you experience any difficulty in obtaining it?
Yes

No

If you answered yes please provide details of the difficulties you experienced:
Q3.
(i)
Do you think the current arrangements for supply and administration of glyceryl trinitrate
are adequate?
Yes

No

(ii)
If No, in what way are they inadequate?
Q4.
Do you think non-health professionals, for example carers and teachers whose organisation
have been appropriately certified and who have undertaken appropriate training, should be
permitted to administer glyceryl trinitrate
Q5.
Yes

No

Please tick the option you agree/disagree with from the following statements
22
(i)
Glyceryl trinitrate should be made more widely available to non-healthcare persons for
use in emergency situations
(ii)
Agree

Disagree

Glyceryl trinitrate should be available in
•
Schools and colleges

•
Sports Centres

•
Other, please specify
Q6.
What do you think would be the main benefits to having wider access to glyceryl trinitrate
for administration in emergency situations by appropriately trained non-medical persons
who have been authorised by an approved body / organisation?
Q7.
What do you think are the main disadvantages and / or safety concerns to widening the
availability of glyceryl trinitrate for administration by appropriately trained non-medical
persons in emergency situations?
Q8.
In your opinion is there sufficient information available for patients about this potentially life
threatening medical condition?
Yes

No

23
Q9.
In your opinion is there sufficient information available for the general public about this
potentially life threatening medical condition?
Yes

No

24