Access to - health.gov.iehealth.gov.ie/.../2015/02/Public-consultation-finalised-ver… · Web viewPublic consultation . Access to. adrenaline, glyceryl trinitrate, salbutamol,

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.

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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 [email protected]

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 [email protected]

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 arrangementsUnder 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

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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 prescriptionThe 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:

LegislationThe 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

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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:

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.

7. 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 doctor-patient 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.

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(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 IrelandThere 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 thigho 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 muscleo 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

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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

registered health professional carer patient organisation family patient teacher member of general public other (please specify)

Q2.(i) 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

(ii) If so, did you experience any difficulty in obtaining it?

Yes

No

If you answered yes please provide details of the difficulties you experienced:

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http://www.hse.ie/eng/health/az/A/Anaphylaxis/Symptoms-of-anaphylaxis.html

Q3.(i) Do you think the current arrangements for supply and administration of adrenaline auto-

injectors 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?

Yes

No

Q5. 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

Agree

Disagree

(ii) Adrenaline auto-injectors should be available in

• Schools and colleges

• Crèches and playschools

• Restaurants

• Sports Centres

• Other, please specify

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Q6. What do you think would be the main benefits to having wider access to adrenaline auto-injectors 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 non-medical 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?

Yes

No

Q9. In your opinion is there sufficient information available for patients about this potentially life threatening medical condition?

Yes

No

Q10. In your opinion is there sufficient information available for the general public about this potentially life threatening medical condition?

Yes

No

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(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


registered health professional carer patient organisation family patient teacher

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http://www.hse.ie/eng/health/az/A/Asthma/

member of general public other (please specify)



Yes

No


Yes

No


Q3.(i) Do you think the current arrangements for supply and administration of salbutamol inhalers

are adequate?

Yes

No


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?

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Yes

No


(i) Salbutamol inhalers should be made more widely available to non-healthcare persons for use in emergency situations

Agree

Disagree

(ii) Salbutamol inhalers auto-injectors should be available in the following settings


• Crèches and playschools

• Sports Centres


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?

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Q8. Do you think medical identification bracelets / cards would benefit persons at risk of asthma attack?

Yes

No


Yes

No


Yes

No

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(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


registered health professional carer

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http://www.hse.ie/portal/eng/health/az/H/Hypoglycaemia/

patient organisation family patient teacher member of general public other (please specify)



Yes

No


Yes

No


Q3.(i) Do you think the current arrangements for supply and administration of glucagon injections

are adequate?

Yes

No


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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?

Yes

No


(i) Glucagon injection should be made more widely available to non-healthcare persons for use in emergency situations?

Agree

Disagree

(ii) Glucagon injection should be available in the following settings


• Sports Centres

• Workplace


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?

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Q8. Do you think medical identification bracelets / cards would benefit persons at risk of a severe hypoglycaemic episode?

Yes

No


Yes

No


Yes

No

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(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


registered health professional carer patient organisation family patient teacher member of general public

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other (please specify)

Q2.(i) Have you or a member of your family or a person under your care ever needed to use

naloxone in an emergency?

Yes

No


Yes

No


Q3.(i) Do you think the current arrangements for supply and administration of naloxone are

adequate?

Yes

No


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?

Yes

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No


(i) Naloxone injections should be made more widely available to non-healthcare persons for use in emergency situations

Agree

Disagree

(ii) Naloxone injections should be available in

• Drug Treatment Service Clinics

• Needle exchange sites

• Friends, family members, partners of drug users


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?

Q8. In your opinion is there sufficient information available for drug users, family members and partners of drug users about opioid overdose?

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Yes

No

Q9. In your opinion is there sufficient information available for the general public about opioid overdose?

Yes

No

(V) Glyceryl trinitrate sublingual spray - used in the treatment of cardiac chest pain (angina)

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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


registered health professional carer patient organisation family patient teacher member of general public other (please specify)

Q2.

21

http://www.hse.ie/eng/health/az/C/Chest-pain/

(i) 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


Yes

No


Q3.(i) Do you think the current arrangements for supply and administration of glyceryl trinitrate

are adequate?

Yes

No


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

Yes

No


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(i) Glyceryl trinitrate should be made more widely available to non-healthcare persons for use in emergency situations

Agree

Disagree

(ii) Glyceryl trinitrate should be available in


• Sports Centres


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?


Yes

No

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Yes

No

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Documents

Access to - health.gov.iehealth.gov.ie/.../2015/02/Public-consultation-finalised-ver… · Web viewPublic consultation . Access to. adrenaline, glyceryl trinitrate, salbutamol,