Contributes to CQC Outcome number: 9&12 Consulted With Post/Committee/Group Date. Pharmacist. Alison Felton Head of Pharmacy/Deputy Chief.

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1 Prescribing paracetamol in adult inpatients at MEHT Type: Clinical Guideline Register No: Status: Public on ratification Developed in response to: In line with Basildon Contributes to CQC Outcome number: 9&12 Consulted With Post/Committee/Group Date Alison Felton Head of Pharmacy/Deputy Chief Pharmacist Feb 18 Professionally Approved By Alison Felton Head of Pharmacy/Deputy Chief Pharmacist March 18 Version Number 1.2 Issuing Directorate Pharmacy Ratified by: Medicines Optimisation and Medication Safety Group Ratified on: 9 th March 2018 Executive Management Board Sign April 2018 Off Date Implementation Date 3 rd April 2018 Next Review Date February 2021 Author/Contact for Information Maria Richards Policy to be followed by (target staff) Clinical Staff Distribution Method Intranet & Website Related Trust Policies (to be read in conjunction with) Document Review History Version Authored/Reviewed by Authored/Reviewed by Issue Date Number 1.0 Maria Richards 3 rd April Maria Richards 4 May Alison Felton 15 May 2018

2 Index 1. Purpose 2. Scope 3. Introduction 4. Paracetamol dosing general 5. Oral and rectal products containing paracetamol 6. Intravenous paracetamol 7. Key prescribing notes 8. Key administration notes 9. Pharmacist role 10. Nursing role 11. Staff and training 12. Equality and diversity 13. Audit and monitoring 14. Communication 15. References

3 1.0 Purpose To minimise the risk of severe hepatic damage due to paracetamol toxicity by ensuring appropriate prescribing and dosing. 2.0 Scope 2.1 This guideline applies to the prescribing of paracetamol in all adult patients at MEHT. 3.0 Introduction 3.1 Paracetamol is the most commonly used analgesic and antipyretic in the world. It is generally regarded as safe and can be bought without a prescription. Despite this fact, paracetamol is the most common cause of drug-induced liver failure through deliberate and accidental overdose. 3.2 Although the usual oral adult dose is generally deemed to be safe, there have been documented reports (one fatal) where patients weighing less than 50kg have suffered liver damage when given the standard dose (1g four times daily). 3.3 The Medicines and Healthcare Products and Regulatory Agency (MHRA) have reviewed the literature since these reports and have concluded that the patients in these case reports had pre-existing risk factors such as chronic malnutrition or high alcohol consumption. Although the MHRA concluded that a patient s weight being less than 50kg is not in itself an indication to reduce the dose of oral paracetamol, consideration should be given to lowering the dose in patients with other conditions likely to pre-dispose them to liver damage from paracetamol. Low body weight is often an indication that patients may have other chronic conditions which increases their risk of toxicity. 3.4 In contrast to oral paracetamol, the need to reduce the intravenous dose of paracetamol in low body weight patients is well documented. 3.4 These guidelines have been drawn up to advise clinicians and ensure that care is taken when deciding on oral and intravenous doses of paracetamol for patients weighing less than 50kg. 4.0 Paracetamol dosing general 4.1 Accurate weight should be documented on the drug chart prior to dosing. NB. If patient cannot be weighed and they are clearly >50kg, this should also be noted. 4.2 Some patients are considered high risk for hepatotoxicity with paracetamol. Dose reduction (see sections 5 and 6) is required for patients with the one or more of the following risk factors: Low body weight: less than 50kg Hepatic impairment

4 Chronic alcoholism Dehydration Receiving enzyme inducers chronically e.g. rifampicin, phenytoin Risk factors for glutathione depletion e.g. HIV, cystic fibrosis Chronic malnutrition NOTE: IV paracetamol is contra-indicated in severe hepatocellular insufficiency 4.3 Only one route of paracetamol can be prescribed- IV/PO is not acceptable as the doses are not interchangeable. 5.0 Oral and rectal products containing paracetamol 5.1 The following table is an aid to dosing patients who require oral or rectal paracetamol taking into consideration the risk factors for hepatotoxicity in section 4: Weight Single dose Maximum daily dose 33-40kg regardless of risk 500mg up to four times daily* 60mg/kg up to 2g in 24 factor(s) 41-49kg with risk factor(s) 41-49kg without risk factor(s) >50kg with risk factor(s) mg up to four times daily* 500mg-1g up to four times daily* 500mg 1g up to 4-8 hourly (depending on dose) up to four times daily* 3g in 24 4g in 24 3g in 24 >50kg without risk factor(s) 1g four times daily* 4g in 24 *In patients who have a creatinine clearance of 10 ml/min, the dosing frequency should be increased to a minimum of Intravenous paracetamol 6.1 The following tables are an aid to dosing patients who require intravenous paracetamol taking into consideration the risk factors for hepatotoxicity in section 4: Table 2: Dosing for intravenous paracetamol Weight Single dose Maximum daily dose 33-50kg regardless of risk factors 15mg/kg every 4-6 * (max four times daily) 60mg/kg up to 3g in 24 >50kg with risk factors 1g every 8 60mg/kg up to 3g in 24 >50kg without risk factors 1g every 4-6 * (max four times daily) 60mg/kg up to 4g in 24

5 *In patients who have a creatinine clearance of 10ml/min, the dosing frequency should be increased to a minimum of 6. Table 3: Dose banding for intravenous paracetamol in low body weight adult patients (15mg/kg) Weight (kg) Dose (mg) Volume (ml) of 10mg/ml solution The use of intravenous paracetamol should be reviewed every 24, with an oral switch occurring as soon as it is clinically appropriate. 6.3 The dose required must be calculated first in millilitres, with the excess removed from the bottle before the remainder is hung for administration. E.g If 750mg intravenous paracetamol is required, 25ml (10mg/ml) should be removed first and discarded before the remainder is administered. This is to avoid the risk of an excess being administered. 6.4 All doses should be administered over 15 minutes. 7.0 Key prescribing notes 7.1 Check for and discontinue multiple paracetamol prescriptions e.g. PRN and regular, or brand names (Tylex, Solpadol etc) 7.2 Do not prescribe PO/IV CHOOSE ONLY ONE ROUTE o avoid IV in patients taking other medications orally (reserve for patients who are NBM or who are severely nauseous and/or vomiting and unable to keep tablets down) o use liquid or soluble tablets if difficulty in swallowing plain tablets 7.3 IV paracetamol is for short term use only: switch to oral/rectal/nasogastric routes ASAP. Soluble oral paracetamol is available. 8.0 Key administration notes 8.1 Use the minimal size vial for the dose available as 500mg in 50ml and 1000mg in 100ml. 8.2 For doses < 1g: remove any excess dose from the vial before administration to avoid inadvertent infusion of the whole vial. 8.3 Does not require further dilution infuse over 15 minutes

6 8.4 Where glass vial is stocked risk of air embolism towards end of the infusion. Give through a pump if given via a Central Venous Catheter. 9.0 Pharmacist role 9.1 Prescriptions for IV paracetamol may be changed by the pharmacist to PO paracetamol if no other contra-indications to the oral route are present. Amendments to the route of administration will be endorsed with initial and date Nursing role 10.1 Nursing staff will record an accurate weight for the patient on the drug chart (in addition to in the nursing notes) Any concerns regarding the route of administration will be highlighted to the physician looking after the patient, particularly where paracetamol is prescribed intravenously this is to ensure timely and appropriate review of the need for continued IV paracetamol Where a patient is having swallowing difficulties with tablets, nursing staff will highlight this to pharmacy so that soluble tablets or liquid may be ordered instead. There is no need to switch to IV paracetamol if the patient can manage alternative formulations Staff and training 11.1 All medical and nursing staff are to ensure that their knowledge, competencies and skills are up to date During induction, staff will receive instruction on current policies and guidelines and how to access them This guideline will be placed on the Trust intranet under Medicines Management and attached to the relevant section of the ebnf Equality and diversity 12.1 The Trust is committed to the provision of a service that is fair, accessible and meets the needs of all individuals Audit and monitoring 13.1 Pharmacy will monitor prescriptions for paracetamol during routine ward visits and when reviewing charts in the dispensary. Any concerns will be reported to the physician responsible for the patient Where appropriate, any risk events involving paracetamol will be reported via the Datix system.

7 14.0 Communication 14.1 Once professionally approved and ratified by DRAG, this policy will be placed on the intranet under the Medicines Management section References Paracetamol dosing in adults with low body weight. CP/PT/ Basildon and Thurrock University Hospitals. August 2017 Paracetamol dose-banding for high-risk patients (adults). MMG021 V3 British National Formulary (accessed 10/1/18) Summary of Product Characteristics. Perfalgan 10mg/ml solution for infusion. Available via (accessed ) Renal Drug Database (accessed )