Safe use of HYDROmorphone CLINICAL EXCELLENCE COMMISSION Medication Safety and Quality Unit February 2016

Session Objectives: The objectives of this presentation are to: Provide a brief overview of HYDROmorphone formulations available Describe recognised risks associated with HYDROmorphone storage and handling Discuss strategies to address risks

What is HYDROmorphone: It is a potent opioid analgesic It is used to manage moderate to severe acute or chronic pain It is 5 – 7 times STRONGER than morphine HYDROmorphone is NOT morphine Errors involving its use can result in fatal over-dose

HYDROmorphone formulations HYDROmorphone is manufactured in a variety of oral and injectable formulations Oral formulations include: tablets – variety of strengths, including immediate release and modified release oral liquid Injectable formulations include: 2mg/ml and 10mg/ml (high potency)

HYDROmorphone overdose symptoms respiratory depression extreme drowsiness cold and/ or clammy skin pupillary constriction bradycardia and hypotension (MIMS Australia, 2015)

HYDROmorphone incidents Fatal and near fatal overdose incidents have been reported within Australia and internationally In 2013 HYDROmorphone was the 15th most frequently reported medicine in clinical incidents in NSW (NSW Clinical Excellence Commission, 2014)

Errors associated with HYDROmorphone use have arisen from: Complexity of branded products leading to incorrect product selection Use of fractional doses Confusion between look-alike, sound-alike names of HYDROmorphone and morphine

Complexity of branded products Hydromorphone is available in multiple strengths and dose forms: Immediate release tablets Immediate release oral liquid 1mg/ml Controlled-release tablets Injectable - immediate release and high- potency

Immediate release tablets Dilaudid® tablets Available in 2mg, 4mg, 8mg strengths May be given several times a day

Immediate release oral liquid Dilaudid® oral liquid 1mg/ml May be given several times a day

Controlled release tablets Jurnista® controlled release tablets Available in 4mg, 8mg, 16mg, 32mg, 64mg strengths Only given once a day

Injectable formulations Injectable Dilaudid® 2mg/ml Available as 1mL ampoules

High-potency injectable Injectable Dilaudid® – HP high-potency 10mg/ml Available as 1mL, 5mL and 50mL ampoules

Case 1: Complexity of branded products A patient was prescribed oral HYDROmorphone 4mg modified release once a day. The nurse erroneously administered 4mg of an immediate release HYDROmorphone formula. Fortunately there was no adverse outcome for the patient. Extreme care needs to be taken during product selection. Errors have occurred when modified release tablets have been selected instead of immediate release and vice versa. This type of error is not uncommon. In addition to prescribing using the generic name, facilities may encourage the use of the brand name to define HYDROmorphone products.

Use of fractional doses Fractional doses may be necessary due to the high potency of HYDROmorphone e.g. HYDROmorphone 0.25mg They can lead to errors associated with incorrect or unclear decimal point placement

Confusion between Look-alike, sound-alike drug names Tall Man lettering may assist in reducing look-alike errors

Case 2: Look-alike sound-alike drug names A patient was prescribed morphine 5mg subcutaneously. The administering nurses erroneously selected and administered HYDROmorphone 5mg. This was equivalent to a dose of 25-35mg morphine. The outcome was fatal for this patient. Incidents have occurred when the similarity in drug name has led nurses to believe that HYDROmorphone was in fact morphine. Storing HYDROmorphone separately from morphine in the S8 drug storage unit will provide another barrier to incorrect product selection.

When administering HYDROmorphone Use a second person check when witnessing and checking HYDROmorphone (NSW Health, 2013). The second person is responsible for: confirming the identity of the patient confirming the selection of the correct medication confirming that the dose and calculations are correct for an infusion, confirming that the infusion pump or syringe driver has been correctly set countersigning the administration on the medication chart against that of the administering person (NSW Health, 2013) The presenter should describe medication reconciliation and pharmacy review processes in their facility. The presenter should describe additional safety mechanisms in place, for example additional labelling using tall man lettering – HYDROmorphone.

To minimise the risk of error: Separate from morphine and oxycodone in Schedule 8 medication storage unit Consider recording HYDROmorphone in a separate Schedule 8 Drug Register Return unnecessary HYDROmorphone to the pharmacy department Don’t stock high-potency HYDROmorphone in ward areas unless there is a clinical need Return HYDROmorphone to pharmacy departments – The presenter should describe facility policy and procedures for returning unnecessary HYDROmorphone stock to pharmacy department. Separate from morphine in Schedule 8 medication storage unit. The presenter should describe policy and procedures for separating HYDROmorphone from other medicines in the S8 drug cabinet in their facility. The presenter should describe additional safety mechanisms in place, for example additional labelling using tall man lettering – HYDROmorphone.

To minimise the risk of error: Use opioid dose calculator tools for dose adjustment Prioritise medication reconciliation and pharmacy review Use Tall Man lettering to reduce risk of confusion with morphine e.g. HYDROmorphone The presenter should describe medication reconciliation and pharmacy review processes in their facility. The presenter should describe additional safety mechanisms in place, for example shelf-labelling or additional product labelling using tall man lettering – HYDROmorphone.

The key messages: HYDROmorphone is NOT morphine HYDROmorphone is 5 – 7 times STRONGER than morphine HYDROmorphone is available in a variety of formulations and strengths HYDROmorphone errors may result in serious adverse patient outcomes

References and resources Australian Commission on Safety and Quality in Healthcare. National Tall Man Lettering 2014; Available from: http://www.safetyandquality.gov.au/our-work/medication-safety/safer-naming-labelling-and-packaging-of-medicines/national- tall-man-lettering/. MIMS Australia (2015) https://www.mimsonline.com.au.acs.hcn.com.au NSW Clinical Excellence Commission. Medication Safety and Quality Program. Tall Man Lettering http://www.cec.health.nsw.gov.au/programs/medication-safety/tall-man-lettering#navigation NSW Clinical Excellence Commission. Patient Safety. Clinical incident management in the NSW Public Health system. http://www.cec.health.nsw.gov.au/clinical-incident-management (accessed February 2016) NSW Ministry of Health HYDROmorphone: High-risk analgesic. Safety Alert number 004/11 http://www.health.nsw.gov.au/sabs/Pages/default.aspx NSW Ministry of Health. (2015) High-Risk Medicines Management. http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_029.html NSW Ministry of Health. (2013) Medication Handling in NSW Public Health Facilities http://www.health.nsw.gov.au/pharmaceutical/Pages/medication-handling-pubhealth.aspx. NSW Ministry of Health Medication Incidents Involving HYDROmorphone (Opioid). Safety Notice 011/10 http://www.health.nsw.gov.au/sabs/Pages/default.aspx

Thank you Questions For further information: CEC-medicationsafety@cec.health.nsw.gov.au www.cec.health.nsw.gov.au