Adverse Drug Reactions in Children – International Surveillance and Evaluation (ADVISE)

Rashed, Asia N; Wong, Ian C. K.; Cranswick, Noel; Hefele, Barbara; Tomlin, Stephen; Jackman, John; Lee, Kenneth Kwing-Chin; Hon, Kam Lun; Ong, Ju Lynn; Ghaleb, Maisoon; Chua, Siew Siang; Hui, Tea Ming; Rascher, Wolfgang; Neubert, Antje

doi:10.2165/11597920-000000000-00000

Cited by 50 publications

(65 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Nevertheless, opioid use was more common on paediatric general medical wards in the remaining centres with frequencies between 14.6-21.6%. One reason for this observation could be that the studied patients in UK and AUS were admitted with more painful conditions [16,18]. Other reasons may be greater fear of opioid use, e.g.…”

Section: Discussionmentioning

confidence: 99%

“…The findings presented are derived from a sub-analysis of the ADVISE (Adverse Drug Reactions in Children -International Surveillance and Evaluation) study [16]. ADVISE was a prospective, multicentre, observational cohort study conducted on five paediatric general medical wards in Australia (AUS), Germany (GER), Hong Kong (HK), Malaysia ).…”

Section: Methodsmentioning

confidence: 99%

“…ADVISE was a prospective, multicentre, observational cohort study conducted on five paediatric general medical wards in Australia (AUS), Germany (GER), Hong Kong (HK), Malaysia ). Further details on the methodology of that study, cohort description and overall drug utilisation are described elsewhere [16][17][18].…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

et al. 2016

Self Cite

View full text Add to dashboard Cite

Key points• Use of analgesic and anti-inflammatory drugs was in line with local recommendations and WHO guidelines • Oral paracetamol and oral ibuprofen are the most commonly used analgesic drugs on general paediatric wards • Differences regarding dose and frequency of ibuprofen and paracetamol use were observed, indicating that safety concerns for individual drugs are perceived differently among countries BOTZENHARDT et al. 2/1 2016-09-16 ABSTRACT AimAnalgesic and anti-inflammatory drugs are frequently prescribed in paediatrics. Prescribing and dosing patterns in hospitalised children are not well known. This study explores analgesic drug utilisation on five paediatric wards and discusses its findings in comparison with WHO guidelines. MethodA sub-analysis of a prospective, multi-centre, observational cohort study was undertaken. Prescription data of children aged up to ≤18 years were collected between October 2008 and December 2009 on paediatric general medical wards in five hospitals in Australia, Germany, the United Kingdom (UK), Hong Kong (HK) and Malaysia. Analgesic drug prescriptions were analysed for prescribing patterns in terms of dosing, frequency and route of administration. Dosing data were compared with local recommendations and WHO guidelines for children. ResultsIn the study cohort 56.8% (726/1,278) of paediatric patients received at least one analgesic drug prescription (1,227 prescriptions). Median age of patients with analgesics was 2.2 years (IQR 0.8-7.3) and median number of prescriptions per patient was 1 (IQR 1-2). Most commonly prescribed drugs were oral paracetamol (45.9%, 563/1,227) and oral ibuprofen (19.9%, 244/1,227). Daily doses of paracetamol ranged from 30 mg/kg/day in Germany to 67-68 mg/kg/day in UK and HK (p<0.05). For ibuprofen, single doses ranged from 5-6 mg/kg in HK and UK to 10 mg/kg in GER and AUS (p<0.001). Opioid use prevalence was statistically different between the centres and ranged from 0% to 17.6% (p<0.001). ConclusionThis study provides a comprehensive overview of analgesic drug use of hospitalised children. Similar to primary care data, paracetamol is the most commonly used analgesic. As recommended by WHO guidelines, oral medication was favoured and opioids used in addition to paracetamol and ibuprofen. Overall drug utilisation was in line with local recommendations and WHO guidelines. Differences in use of paracetamol and ibuprofen among countries was seen indicating that safety concerns are perceived differently. More large-scale safety studies are needed. BOTZENHARDT et al.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

et al. 2016

Self Cite

View full text Add to dashboard Cite

show abstract

“…2 In 2012, an international evaluation of adverse drug reactions (ADRs) among children aged 0 to 18 years revealed that approximately 20% of all ADRs were attributable to cough and cold preparations containing analgesics or opioids. 3 Within the past several years, an increasing number of case reports have illustrated clinically important respiratory depression and even death among infants and children receiving opioids for pain control particularly following tonsillectomy and adenoidectomy (T&A). In 2007, a previously healthy 29-month-old patient received acetaminophen and codeine after tonsillectomy and on post-op day 2, experienced severe apnea and subsequent brain injury.…”

Section: Introductionmentioning

confidence: 99%

Opioid Use and the Risk of Respiratory Depression and Death in the Pediatric Population

Whittaker

2013

The Journal of Pediatric Pharmacology and Therapeutics

View full text Add to dashboard Cite

BACKGROUND Pediatric patients may be at an increased risk of adverse effects from various medications. Recently, there have been a number of serious adverse events, including several pediatric patients experiencing severe respiratory depression and death as a result of the use of codeine for pain control following tonsillectomy and adenoidectomy. OBJECTIVE To assess the safety of opioid agonists in pediatric patients undergoing operative procedures or have experienced trauma and to evaluate the risk of respiratory depression and death among this population. METHODS PubMed and Medline were searched to identify randomized controlled studies from 1994 to 2012 addressing postsurgery/trauma opioid use in pediatric patients. Relative risks and confidence intervals (CIs) were calculated using data available in clinical trials. RESULTS A total of 16 clinical trials were evaluated for this review. Randomized controlled trials included studies comparing opioids versus non-opioids for a variety of painful conditions. The relative risk of respiratory depression associated with opioid use in 1 trial was 1.63 (95% CI: 0.64-6.13). The remaining 15 trials reviewed described no significant difference in respiratory depression or adverse effects associated with treatment. No deaths were attributed to opioid use in any of these studies. CONCLUSION Opioid-associated respiratory depression was very rare and no deaths were reported in the reviewed studies. These findings under the well-defined conditions of controlled studies may not be the best means of determining overall opioid-associated side effects in pediatric patients. INDEX TERMS

show abstract

“…[1][2][3][4] These infusions require complex dose calculations, multiple manipulations and complicated administration rate adjustments. The project aimed to minimise the risk of medication errors in nurse-or patient-controlled analgesia (N/PCA) for children.…”

mentioning

confidence: 99%

Delivering Safe Opiate Infusions for Analgesia in Children

et al. 2015

Self Cite

View full text Add to dashboard Cite

Aim Opiate infusions are essential therapy for children with severe pain, but have been associated with serious medication errors. [1][2][3][4] These infusions require complex dose calculations, multiple manipulations and complicated administration rate adjustments. The project aimed to minimise the risk of medication errors in nurse-or patient-controlled analgesia (N/PCA) for children. Method A system management approach was developed to minimise complex calculations and individualised medicine manufacture by providing standard dose-banded concentrations of morphine infusion, manufactured aseptically, for N/PCA administration using pre-programmed safety pumps. The new system was implemented in three phases:1. Pre-implementation: Direct observation in theatres and wards of current practice; analysis of individually prepared syringes; focus groups (ward nurses, recovery nurses, and anaesthetists) on the current practice; Product design: packaging and labelling; Failure mode & effect analysis. 2. Implementation: Reconfiguration of the smart pumps with the new morphine standardised concentrations protocols; production of new colour-coded protocols, labels and standard operating procedures for ward/theatres use; evaluation of storage of the new product in different areas. 3. Post-implementation: direct observation of administration process of morphine standardised prefilled syringe (PFS); focus groups on the new system (morphine PFS); 6-month follow up study after full roll out. Results Observation of morphine infusions (153) prepared by healthcare professionals for 128 children (7.5±5.6 years; mean±SD) identified major differences in preparation methods. Analysis of the individually prepared infusions (78) identified that 61.5% deviated from the target concentration by greater than the pharmacopoeial limit (±7.5%), of which 75% (36/48) were in excess with 28% (10/36) deviating by more than +20%. A variety of preparation practices led to the out-of-specification results, including lack of appreciation of the overage in morphine ampoules; "Say I've got 27 kg child, and you have to put 27 mg in. I'll always put the 20 mg, all of the ampoules in, as I opposed to drawing it up in a syringe I will be losing some and I want to make sure that I get what I think in my head is 27, so the first 2 will get the full ampoule and only the last 7 mg that I will draw up in a 1 mL syringe." (Anaesthetist). Three standardised concentrations of morphine were established: 3 mg/50 mL glucose 5% for weight ≤3.99 kg 10 mg/50 mL sodium chloride 0.9% for weight ≥4 kg -19.9 kg 50 mg/50 mL sodium chloride 0.9% for weight ≥20 kg Pilot implementation of standardised morphine infusions (35 to date) was well-received by anaesthetists and nurses. Colour coded protocols and labels were regarded as lowering the risk of wrong selection. Conclusion The project addressed the unacceptable variation identified in individually prepared medicines and simplified their administration. Whilst it is known that standard concentration morphine infusions can be u...

show abstract

Adverse Drug Reactions in Children – International Surveillance and Evaluation (ADVISE)

Cited by 50 publications

References 37 publications

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

Opioid Use and the Risk of Respiratory Depression and Death in the Pediatric Population

Delivering Safe Opiate Infusions for Analgesia in Children

Contact Info

Product

Resources

About