THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email: Website: Weee Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 denise@paediatrics.org.nz www.paediatrics.org.nz 26 January 2011 Greg Williams Therapeutic Group Manager PHARMAC P.O. Box 10-254 Wellington 6143 Email: greg.williams@ Pharmac.govt.nz Dear Greg RE: Restrictions for dispensed volumes of paracetamol liquid The Paediatric Society of New Zealand (PSNZ) would like PHARMAC to review the volume restrictions for paracetamol liquid dispensed by community pharmacies. We have gathered anecdotal information from the PSNZ listserver that large volumes of paracetamol liquid are sometimes being issued as STAT dispensings by community pharmacies eg one litre or more. Paracetamol remains the most common substance requiring hospital referral for children for overdose ingestion. Those children who achieve potentially toxic blood levels have usually had access to large volumes of liquid paracetamol ie more than 200ml of 250mg in 5ml. While it has been suggested that significant hepatic injury in children is extremely rare (1) it is our experience, both in New Zealand and the UK, that some childhood paracetamol poisonings come close to and even require a liver transplant, albeit rarely. The children most at risk are those under 5 years of age who are tempted to drink whole bottles of liquid “because they like the taste”. An additional concern with the large volume dispensing is the difficulty in securing one litre bottles with safety caps as we understand this size of safety cap is not available in New Zealand. These large bottles may also be more difficult to store in high cabinets, therefore ending-up in more-accessible/less safe areas such as bench tops and low cupboards, We are also aware of families that keep these large volumes of paracetamol liquid for use by various family members over a number of years. The dispensed bottle will have dosing instructions for one patient, at a particular age, but no dosing information for other family members. Smaller dispensed volumes may reduce the potential for families to participate in this practice with its associated risk of medication error. Hepatic injury from paracetamol in the < 6 year old age group is reported following a single ingestion of > 200mg/kg body weight. (1) This equates to a 3 gram or more ingestion by a 15 kg child (average weight for a 2 to 3 year old). We suggest that the incidence of paracetamol poisoning among young children could be limited by the introduction of the following recommendations: 1. A 200ml volume restriction for dispensed paracetamol liquid. This equates to a maximum dispensing of 10 gram of paracetamol which would be approximately one weeks therapeutic dosing. Ingestion of this total volume would still be potentially toxic to a young child; however the risk is significantly reduced. “Health of our children: Wealth of our nation” 2. An exemption to this supply restriction could apply for situations where paracetamol liquid is required for the management of chronic pain eg. for children and adults who are unable to swallow tablets. In these cases the prescriber could endorse the prescription “Certified condition – condition identified in writing” We look forward to discussing this further with you if more clarification is needed. Kind regards Brenda Hughes Convenor Pharmacist/Therapeutics SIG Paediatric Society of NZ Julie Chambers Dr Michael Shepherd Child Injury Prevention Clinical Director Starship Trauma ServiceChildren’s Emergency Dept Starship Children’s Hospital Letter endorsed by: Dr Rosemary Marks, President, Paediatric Society of NZ Dr Simon Rowley, Consultant Paediatrician/Neonatologist, Auckland City Hospital (ACH) Dr Diana Purvis, Paediatric Dermatologist, Starship Children’s Hospital Andrew Sutton, Pharmacy Team Leader, Womens & Children’s Health, ACH Dianne Wright, Clinical Advisory & Paediatric Pharmacist, Taranaki Base Hospital Caroline De Luca, Senior Paediatric and Formulary Pharmacist, Auckland City Hospital Roisin Daly, Senior Paediatric Oncology Pharmacist, Auckland City Hospital Reference: 1. Daly F, Fountain J, Murray L et al. Guidelines for the management of paracetamol poisoning in Australia and New Zealand – explanation and elaboration. MJA 2008;188: 296-301.