November 2017 Vol.15 Medication Safety Bulletin The Medication Safety Bulletin (MSB) is published by the Medication Safety Committee HAHO (MSC) biannually (May and Nov) as an educational publication to share issues related to medication safety. Please refer to the HA Risk Alert (HARA) for sharing of medication incident cases reported in HA. Inside this issue: Update of Medication Safety Guidelines issued by MSC Neuroleptic malignant syndrome: a rare adverse drug reaction Risk of hepatitis B reactivation P.1 P.2 P.3 Hong Kong West Cluster Sharing on Continuous Quality Improvements on Near Miss P.4 T his year’s Medication Safety Forum would be held on 6 December 2017 (Wednesday) at Lecture Theatre, HA Building. With the theme Near Miss Management – Reporting, sharing and learning, we wish to promote the culture of Near Miss Management on reporting (at department level), sharing (at hospital level) and learning (at staff level). Similar to previous years, continuous improvement measures in medication safety would also be shared by staff from various hospitals. We hope you would enjoy the time sharing and learning together! T Update of Medication Safety Guidelines issued by MSC he MSC has recently reviewed and updated the following HA Guidelines, with endorsement by the Drug Management Committee (DMC). 1. The HA Guideline on Look-Alike Sound-Alike Medications is a new guideline formulated from the Safety Solutions on Look-Alike Sound Alike Medications, which aims to suggest measures to mitigate risks associated with look-alike sound-alike medications (LASA). 2. The Safety Solutions on High Alert Medications (previously known as Safety Solutions on High Risk Medications) suggests updated potential risks and possible system improvement strategies regarding high alert medications. This document serves to supplement guidelines and recommendations issued by the MSC. The descriptions of the 9 categories of high alert medications are also updated as follows: HA List of High Risk Medications (2010) HA List of High Alert Medications (2017) Concentrated electrolytes Concentrated electrolytes Cytotoxic chemotherapy Chemotherapeutic agents (parenteral and oral) Drugs commonly associated with drug allergies e.g. penicillin, aspirin, NSAIDs Drugs commonly associated with drug allergies (e.g. penicillin, aspirin, NSAIDs) Vasopressors and inotropes Vasopressors and inotropes Anticoagulants including heparin Anticoagulants (parenteral and oral) Neuromuscular blocking agents (e.g. atracurium, pancuronium) Neuromuscular blocking agents (e.g. atracurium, rocuronium) Oral hypoglycaemics Oral hypoglycaemics Insulins Insulins Narcotics (e.g. fentanyl)/opioids Narcotics (e.g. fentanyl) and opioids Guidelines and recommendations issued by the MSC can be accessed in HA intranet via below links: Via hadf.home - http://hadf.home/Document-Form-and-Publication/Documents-and-Forms Via cpo.home - http://portal.home/sites/cpo/committees/msc/guidelines/default.aspx Online version of this Bulletin is available in HA intranet website (ha.home) Page 2 N Medication Safety Bulletin Vol.15 Neuroleptic malignant syndrome: a rare adverse drug reaction euroleptic malignant syndrome (NMS) is a rare adverse reaction to antipsychotic agents and, less commonly, to dopamine antagonists. It leads to autonomic dysfunction and can be fatal if not recognised early. The incidence of NMS is estimated at 0.01%–0.02% of patients treated. Signs and symptoms of NMS include severe elevation of body temperature, muscle rigidity, sudden change in mental status, and a depressed level of consciousness. The syndrome is more commonly associated with traditional antipsychotics such as haloperidol, fluphenazine and chlorpromazine; but it can also occur with newer, non-traditional antipsychotics such as quetiapine, risperidone and olanzapine. Several clinical, systemic, and metabolic factors have been correlated with the incidence of NMS, including agitation, dehydration, restraint, preexisting abnormalities of CNS dopamine activity or receptor function, and iron deficiency. Nearly all case series of NMS patients have reported physical exhaustion and dehydration prior to the onset of NMS. Elevated environmental temperature has been proposed as a contributing factor in some series. Healthcare professionals should be familiarised with the clinical Elevated body temperature is one features of NMS and vigilant in detecting early signs. Primary management of of significant symptoms for early NMS lies in prevention through conservative use of antipsychotics, reduction recognition of NMS of risk factors, early diagnosis, prompt discontinuation of offending medications, and medical management. Although the onset of NMS can occur at any time during exposure to an implicated drug, most cases arise when the drug is first started or when the dosage is increased or the drug is rapidly titrated. It is prudent to verify with patients for any previous reactions to these drugs before prescribing, dispensing and administration. Any history of extrapyramidal symptoms should be investigated and documented in the patient record. Healthcare professionals are also encouraged to report any adverse events caused by drugs to HA (via AIRS) and Department of Health (via ADR Reporting webpage www.drugoffice.gov.hk/adr.html). ADR Online Reporting Drug Office, Department of Health ADR Reporting Template Available in AIRS Page 3 Risk of hepatitis B reactivation I n 2016, the US Food and Drug Administration (FDA) issued a drug safety alert regarding the risk of hepatitis B virus (HBV) reactivation in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antivirals (DAAs) for hepatitis C virus. List of Direct-Acting Antivirals (DAAs) *Not registered in Hong Kong Brand name Daklinza Epclusa Harvoni Olysio Sovaldi Viekira Pak Viekira Pak XR* Technivie* Zepatier* Active ingredient (s) Daclatasvir Sofosbuvir and Velpatasvir Ledipasvir and Sofosbuvir Simeprevir Sofosbuvir Dasabuvir, Ombitasvir, Paritaprevir and Ritonavir Dasabuvir, Ombitasvir, Paritaprevir and Ritonavir Ombitasvir and Paritaprevir and Rtonavir Elbasvir and Grazoprevir FDA would require a Boxed Warning, the most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing healthcare professionals to screen and monitor for HBV in all patients receiving DAA treatment. FDA also advised that healthcare professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. In Hong Kong, approximately 10% of the population is serologically positive for hepatitis B virus surface antigen (HBsAg) and another 40% has a previous history of hepatitis B infection, positive for hepatitis B surface antibody (anti-HBs), hepatitis B core antibodies (anti-HBc), or both. Apart from DAAs, hepatitis B reactivation can also occur in patients with hepatitis B infection receiving immunosuppressive therapy (e.g. chemotherapy, steroid), and can potentially lead to significant flare with liver failure and mortality. Current evidence showed that pre-emptive use of antiviral drugs could reduce the risk of HBV reactivation and its related hepatitis flares. The risk of HBV reactivation varies with different immunosuppressive agents. In Hospital Authority, there are two guidelines available to healthcare professionals, as reference in the pre-emtive use of nucleos(t)ide analogues in patients with Hepatitis B infection. Clinicians should exercise their clinical judgment in the management of each individual patient. Explanation and informed decision to patients are also important. Page 4 Medication Safety Bulletin Vol.15 Hong Kong West Cluster Sharing on Continuous Quality Improvements on Near Miss H ong Kong West Cluster has the following initiatives to promote medication safety and learning from near miss: 1. Quality Reminder In collaboration with Quality & Safety Department to promulgate medication safety messages for doctors, nurses and pharmacists 2. Medication Safety Posters To provide information to enhance medication safety on wards Safe Use on Insulin Pen Devices Use of abbreviations in Prescriptions 3. Drug Information Tables Oxycodone preparations available in QMH To help nurses and pharmacists to avoid mixing up of medications with similar drug names and multiple dosage forms 4. Medication Safety Pearls To raise awareness of Pharmacy staff for near misses of medication Insulin preparations available in QMH Comparison table of Influenza Vaccines This Bulletin is prepared by the Chief Pharmacist’s Office, HAHO Sharing of near miss in picking intravenous dangerous drugs