Guideline for the use of Naloxone in Adults

Transcription

1 Guideline for the use of Naloxone in Adults Controlled document This document is uncontrolled when downloaded or printed Reference number Version 1 Authors WHHT: MM098 Date ratified February 2016 Committee: Issue date 02/03/2016 Review date February 2019 Target audience Key Words Previous Policy Name Sharon Howarth, Lead Medicines Safety & Audit Pharmacist Medicines Use & Safety Panel Doctors, Nurses, Pharmacists Naloxone, opioids Authors: Sharon Howarth Review Date: February 2019 Page 1 of 11

2 CONTRIBUTION LIST Key individuals involved in developing this version of the document Name Sharon Howarth Dr Sharon Chadwick Designation Lead Medicines Safety & Audit Pharmacist Palliative Care Consultant Approved by Committee Medicines Use & Safety Panel Change History Version Date Author Reason 1 February 2016 Sharon Howarth New Guideline Authors: Sharon Howarth Review Date: February 2019 Page 2 of 11

3 CONTENTS 1. Introduction Purpose and Scope Roles and Responsibilities Naloxone dosing guidance Higher initial dosing regimens Intravenous administration Higher initial dosing regimens Intramuscular administration Lower initial dosing regimens Intravenous administration Ongoing emergency treatment and the role of continuous naloxone IV infusions Cautions Adverse Reactions References Equality Impact Assessment Policy Ratification Form Authors: Sharon Howarth Review Date: February 2019 Page 3 of 11

4 1. Introduction Naloxone is a highly effective antidote for opioids and opiates. It is used across a range of care settings where opioid and opiate use is common including the management of drug misuse and dependence, chronic pain, and occasionally in palliative care 1. Total antagonism of opioid effects in those taking long term opioids can lead to hyperalgesia, severe pain, severe physical withdrawal symptoms and in extreme cases cardiac arrest, therefore the risk of naloxone use must be weighed against the benefits of treatment. A patient safety alert was issued by NHS England in vember 2014 and subsequently in October 2015 to further raise awareness of the risk of harm or death from inappropriate doses of naloxone in patients on long-term opioid or opiate treatment e.g. in chronic pain, palliative care and post-surgery 1, 2, 3. Regardless of the reason for the exposure to opioids, urgent or emergency use of naloxone should only ever be considered where there is an immediate threat to life 1. The primary aim of treatment is to reverse the toxic effects of opioids such that patients are no longer at risk of respiratory arrest, airway loss, or other opioid-related complications. The aim is not necessarily to restore a normal level of consciousness, as in some cases this would be entirely inappropriate e.g. in a dying patient 1. Hence, the first requirement when considering the need for naloxone is to make an assessment of the patient s respiratory rate and depth of breathing, and confirm an unobstructed airway. If the rate is below 8 breaths per minute (for an adult), and there is evidence of opioid use (e.g. appropriate history or pin point pupils), then consider naloxone. 2. Purpose and Scope The purpose of this guideline is to facilitate the correct management of any scenario that requires use of naloxone in an adult (over 16 years of age). Generally, two dosing regimens exist for naloxone. These are: Higher initial dose regimens - used primarily in emergency situations associated with drug misuse and dependence; they are not normally appropriate in palliative care or in those taking long term opioids, for example in chronic pain. Lower initial dose regimens - used where the situation is less immediately lifethreatening. They have use in drug misuse and dependence, (where respiratory depression is less severe and controlled reversal is considered advantageous), in palliative care, and in other circumstances where tailored reversal is necessary, for example conscious sedation/post-operatively. In some circumstances a continuous naloxone infusion may also be warranted. This may be required when the overdose is caused by opioids or opiates with a particularly long halflife, or high receptor affinity, or where overdoses are particularly large, to prevent a lapse into sedation following initial treatment of acute toxicity. This guideline covers these dosing regimens and also aims to ensure that all clinical staff are aware of how to safely administer naloxone. Authors: Sharon Howarth Review Date: February 2019 Page 4 of 11

5 3. Roles and Responsibilities Prescribers responsibilities: To prescribe the correct dose of naloxone depending on the clinical scenario and patient factors. If unsure, contact Pharmacy, Palliative Care or Pain Team. To inform nursing staff of the urgency of the prescription. Nurses responsibilities: To correctly administer the naloxone as per the prescription, local IV guides and/or the Injectable Medicines Guide (available on the Intranet Homepage). If unsure, contact the ward pharmacist for further advice. (If out-of-hours contact the on-call/edc Pharmacist). Pharmacists Responsibilities: To review any prescriptions for naloxone and check they are prescribed correctly (more likely this will be any prescriptions for patients receiving naloxone as an inpatient and not in the emergency setting). To communicate any administration advice, as required, to clinical staff giving naloxone. All incidents that require administration of naloxone should be reported via Datix, as per Trust policy. 4. Naloxone dosing guidance Before initiating naloxone therapy it is important to establish, where possible, what opioid the patient has taken, including dose and route of administration. If relevant, it is also important to consider whether the opioid use is chronic, and the indication. This information will enable a clinical decision to be made as to which dosing regimen to use. 4.1 Higher initial dosing regimens Intravenous administration For emergency use in opioid overdose or intoxication (usually associated with drug misuse and dependence) 4 For situations of severe respiratory depression/arrest and significant urgency: Give naloxone 400 micrograms by intravenous (IV) injection If no response after 1 minute, give naloxone 800 micrograms IV If still no response after another 1 minute, repeat dose of naloxone 800 micrograms IV If still no response, give naloxone 2mg IV (4mg may be required in a seriously poisoned patient), then review diagnosis Further doses of naloxone may be required if respiratory function deteriorates Authors: Sharon Howarth Review Date: February 2019 Page 5 of 11

6 Aim for reversal of respiratory depression, not full reversal of consciousness 5. Naloxone is ready diluted to be given. If the overdose is caused by opioids or opiates with a particularly long half-life, or high receptor affinity, or where overdoses are particularly large, consider a naloxone infusion. See 4.4. If a total cumulative dose of 10 mg naloxone does not produce a significant improvement, this suggests that the respiratory depression is wholly or partially caused by other pathological conditions or active substances other than opioids. 4.2 Higher initial dosing regimens Intramuscular administration For emergency use in opioid overdose or intoxication (usually associated with drug misuse and dependence) Intramuscular administration of naloxone may be used in an emergency for the management of acute overdose for the purpose of saving a life 1. The following intramuscular dose is derived from UK Ambulance Services Guidance: By intramuscular (IM) injection, naloxone 400 micrograms initially, with further 400 microgram doses given incrementally every 3 minutes until an effect is noted, up to a maximum of 4.4mg Lower initial dosing regimens Intravenous administration For tailored reversal (usually in palliative care, for patients already taking regular opioid analgesics for pain, and in post-operative respiratory depression) In the palliative patient already identified as being in the dying phase, becoming unresponsive and having a slowed respiratory rate can be part of the natural progression of their disease in the terminal stages. This may mimic opioid overdose but does not warrant the use of naloxone. In cases of doubt the Palliative Care Team can be consulted for the correct management. Adopt a wait and see approach if: Respiratory rate more than 8 breaths per minute AND Good respiratory depth AND Patient is easily rousable with a sedation score * of 1 or 2 ( AVPU ** score V or P) AND Oxygen saturations more than or equal to target and not cyanosed tes Consider reducing or omitting the next regular dose of opioid or seek specialist advice. Treat if: Respiratory rate 8 breaths per minute and/or poor respiratory depth OR Patient barely rousable or unconscious with a sedation score of 3 (AVPU score U) OR Oxygen saturations are less than target and/or patient is cyanosed OMIT REGULAR OPIOIDS through all routes including removal of opioid patches. In some cases e.g. those requiring opioids through a syringe driver, reducing the dose may be more appropriate. Discuss urgently with the Palliative Care or Pain Team. CONTACT THE MEDICAL TEAM (or on-call, if out of hours) Authors: Sharon Howarth Review Date: February 2019 Page 6 of 11

7 * Sedation Score 0 = awake 1 = drowsy occasionally, easy to rouse 2 = drowsy frequently, easy to rouse 3 = deep somnolent, difficult to rouse S = normal sleep ** Conscious Level A Awake V Voice P Pain U Unresponsive Use the following dosing schedule and prescribe as illustrated below: Prepare naloxone injection: 400 micrograms diluted with sodium chloride 0.9% for injection, made up to 8ml Give naloxone 100 micrograms/2 ml by slow intravenous (IV) injection and observe effect. Repeat assessment of sedation score and respiratory rate If sedation score of 3 (U) or RR of 6 or below, repeat administration of naloxone 100micrograms IV every 2 minutes to keep respiratory rate above 8 Naloxone should not normally be given via intramuscular injection for this indication due to a slower and unpredictable absorption affecting onset of action. IM or subcutaneous administration (SC) should only be considered if IV access cannot be obtained. In palliative care, the preferred route is SC. Patients who require repeated boluses may need an IV naloxone infusion. Close and frequent observations (oxygen saturation and respiratory rate every 15 minutes) should be undertaken in the first 2 hours followed by routine ongoing monitoring for a further 10 hours and review. Extended monitoring may be required for patients receiving modified release preparations or patches, and for those with renal or hepatic impairment. If a patient s pain returns after naloxone administration and this requires treating, seek specialist advice from the Palliative Care or Pain Team. If a patient's respiratory rate and sedation/avpu score are normal 4-6 hours after the last dose of naloxone, they are unlikely to need more. Authors: Sharon Howarth Review Date: February 2019 Page 7 of 11

8 4.4 Ongoing emergency treatment and the role of continuous naloxone IV infusions The duration of action for some opioid formulations is longer than that of the naloxone IV bolus (naloxone has a short plasma half-life of 1-2 hours) 5. For example, methadone, buprenorphine, fentanyl, and prolonged release morphine and oxycodone all have extended durations of action. Therefore, in situations where respiratory depression is known to be induced by such substances or there is a reason to suspect this, naloxone should be administered as a continuous infusion, if initial bolus doses have worn off. The infusion rate is determined according to the individual patient, depending on the response of the patient to the IV bolus and on the reaction of the patient to the IV infusion. The use of the continuous intravenous infusion should be carefully considered and respiratory assistance should be applied if necessary. Prepare naloxone IV infusion: add 2mg to 500ml of sodium chloride 0.9% or glucose 5% (this gives a final concentration of naloxone 4micrograms/ml) OR If patient is fluid restricted: use 10mg diluted with glucose 5% and make up to 50ml (this gives a final concentration of naloxone 200micrograms/ml) Administer via infusion pump. Initial rate is usually 60% of the initial resuscitative intravenous injection dose, per hour. 4 Rate of infusion should be adjusted according to response and level of respiratory depression. 4.5 Cautions te: The initial resuscitative intravenous injection dose is that which maintained satisfactory ventilation for at least 15 minutes. Naloxone must be given with great caution to patients who have received longer-term opioid treatment for pain control or who are physically dependent on opioids. Use of naloxone in patients where it is not indicated, or in larger than recommended doses, can cause a rapid reversal of the physiological effects for pain control, leading to intense pain and distress, and an increase in sympathetic nervous system stimulation and cytokine release precipitating an acute withdrawal syndrome. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest may result from inappropriate doses of naloxone being used for these types of patients 2. Although a direct cause and effect relationship has not been established, naloxone should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation and pulmonary oedema 6. There are rare reports of convulsions following the use of naloxone; however a causal link has not been shown 5. Authors: Sharon Howarth Review Date: February 2019 Page 8 of 11

9 4.6 Adverse Reactions The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include but are not limited to the following: body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, vomiting, nervousness, restlessness, irritability, shivering, trembling, abdominal cramps, weakness and increased blood pressure 6. Abrupt postoperative reversal of opioid-induced respiratory depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest which may result in death 6. Cardiac effects may occur, particularly in patients who are pain controlled by opioids and have pre-existing cardiac disease: hypo-or hypertension, pulmonary oedema, atrial and ventricular fibrillation and cardiac arrest References 1. UKMI Medicines Q&A What naloxone doses should be used in adults to reverse urgently the effects of opioids or opiates? Date prepared June Available through NICE Evidence Search at 2. NHS England Patient Safety Alert. Stage One: Warning. Risk of distress and death from inappropriate doses of naloxone in patients on long-term opioid/opiate treatment. Ref NHS/PSA/W/2014/016. Issued 20 vember NHS England Patient Safety Alert. Stage Two: Resources. Support to minimise the risk of distress and death from inappropriate doses of naloxone. Ref NHS/PSA/Re/2015/009. Issued 26 October British Medical Association/Royal Pharmaceutical Society. British National Formulary. Available online 5. Toxbase factsheet. Naloxone (antidote).national Poisons Information Service. Public Health England. Updated 12/2004. Available online at 6. Summary of Product Characteristics. Naloxone 400mcg/ml solution for injection/infusion. Hameln. Last updated on the emc: 11/11/14. Available online Authors: Sharon Howarth Review Date: February 2019 Page 9 of 11

10 6. Equality Impact Assessment 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems Marriage & Civil partnership Pregnancy & maternity 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? / 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? Comments Authors: Sharon Howarth Review Date: February 2019 Page 10 of 11

11 7. Policy Ratification Form Title: Guideline for the Use of Naloxone in Adults Name of Persons Job Title Date Divisional Support (Direct Line Manager / Matron / Consultant / Divisional Manager) Sharon Howarth Dr Sharon Chadwick Lead Medicines Safety & Audit Pharmacist Palliative Care Consultant Consultation Process (list of stakeholders consulted / staff groups presented to) Endorsement By Panel/Group Jan 2016 Jan 2016 Name of Committee Chair of Committee Date Medicines Use & Safety Panel Peter O Brien Feb 2016 Document Checklist 1. Style & Format Is the title clear and unambiguous? Is the font in Arial? Is the format for the front sheet as per Appendix 1 of the policy framework Has the Trust Logo been added to the Front sheet of the policy? Is it clear whether the document is a guideline, policy, protocol or standard operating procedure? 2. Rationale Are reasons for development of the document stated? 3. Content Is there an introduction? Is the objective of the document clear? Does the policy describe how it will be implemented? Are the statements clear and unambiguous? Are definitions included? Are the responsibilities of individuals outlined? 4. Evidence Base Is the type of evidence to support the document identified explicitly? Are key references cited? Are supporting documents referenced? 5. Approval Does the document identify which committee/group will approve it? 6. Review Date Is the review date identified? Is the frequency of review identified? If so is it acceptable? 7. Process to Monitor Compliance and Effectiveness Are there measurable standards or Key Performance Indicators to support the monitoring of compliance with and effectiveness of the document? Is there a plan to review or audit compliance with the document? Name of Person completing Ratification Form: Job Title / Kate Edmeades Medicines Use & Safety Panel Administrator Feb 2016 Ratification Group/Committee Chair Signature Date Medicines Use & Safety Panel Dr Peter O Brien Feb 2016 Date Authors: Sharon Howarth Review Date: February 2019 Page 11 of 11