Paediatric Rational Prescribing: A Systematic Review of Assessment Tools.

Rational prescribing criteria have been well established in adult medicine for both research and quality improvement in the appropriate use of medicines. Paediatric rational prescribing has not been as widely investigated. The aims of this review were to identify and provide an overview of all paediatric rational prescribing tools that have been developed for use in paediatric settings. A systematic literature search was made of MEDLINE, Embase, CINAHL and IPA from their earliest records until July 2019 for all published paediatric rational prescribing tools. The characteristics of the tools were recorded including method of development, types of criteria, aspects of rational prescribing assessed, and intended practice setting. The search identified three paediatric rational prescribing tools: the POPI (Pediatrics: Omissions of Prescriptions and Inappropriate Prescriptions) tool, the modified POPI (UK) tool, and indicators of potentially inappropriate prescribing in children (PIPc). PIPc comprises explicit criteria, whereas POPI and the modified POPI (UK) use a mixed approach. PIPc is designed for use in primary care in the UK and Ireland, POPI is designed for use in all paediatric practice settings and is based on French practice standards, and the modified POPI (UK) is based on UK practice standards and is designed for use in all paediatric practice settings. This review describes three paediatric rational prescribing tools and details their characteristics. This will provide readers with information for the use of the tools in quality improvement or research and support further work in the field of paediatric rational prescribing.

Modifying a Paediatric Rational Prescribing Tool (POPI) for Use in the UK.

Rational prescribing tools can be used by individual prescribers, organisations, and researchers to evaluate the quality of prescribing for research and quality improvement purposes. A literature search showed that there is only one tool for evaluating rational prescribing for paediatric patients in hospital and outpatient settings. The Pediatrics: Omission of Prescriptions and Inappropriate Prescriptions (POPI) tool was developed in France and comprises 105 criteria. The aim of this study was to modify this tool to facilitate its use in paediatric practice in the United Kingdom (UK). POPI criteria were compared to relevant UK clinical guidelines from the National Institute for Health and Care Excellence, the Scottish Intercollegiate Guideline Network and the British National Formulary for Children. Where guidelines differed, criteria were modified to reflect UK guidance. If there were no relevant guidelines or directly contradictory guidelines, criteria were removed. Overall, no change was made to 49 criteria. There were 29 modified to concord with UK guidelines. Four criteria were reduced to two criteria due to being linked in single guidelines. Twenty-three criteria were omitted, due to the absence of relevant UK guidance or directly conflicting UK practice, including one entire clinical category (mosquitos). One category title was amended to parallel UK terminology. The modified POPI (UK) tool comprises of eighty criteria and is the first rational prescribing tool for the evaluation of prescribing for children in hospital and outpatient settings in the UK.

Observational study on the palatability and tolerability of oral prednisolone and oral dexamethasone in children in Saudi Arabia and the UK.

BACKGROUND: Short-course oral corticosteroids are routinely used to treat acute asthma and croup. We evaluated their tolerability and palatability in Saudi Arabian (SA) and UK children. METHODS: Prospective observational/interview study (3 months in each country). Palatability was evaluated using a 5-point facial Hedonicscale and tolerability by direct questioning of patient/parents. RESULTS: In SA, of 122 patients (2-10 years) recruited, 52 received prednisolone base tablets, 37 prednisolone sodium phosphate syrup and 33 received dexamethasone elixir. In the UK, of 133 patients (2-16 years), 38 received prednisolone base tablets (mainly crushed and dispersed), 42 prednisolone sodium phosphate soluble tablets and 53 received dexamethasone sodium phosphate oral solution.In both countries, dexamethasone had the highest palatability scores (SA mean: 1.97; UK mean: 3) and prednisolone base tablets had the lowest (SA mean: 1.12; UK mean: 1.39). Palatability scores improved for all formulations of prednisolone with each subsequent daily dose.In SA, prednisolone base tablets were associated with more nausea (24vs7 patients) and vomiting (5vs0 patients) than sodium phosphate syrup (p=0.008 and p=0.073, respectively). In the UK, vomiting occurred more frequently with prednisolone base (8 patients) than sodium phosphate soluble tablets (2 patients) (p=0.041).In both centres, dexamethasone was associated with less side effects. Vomiting (1vs0 patients), nausea (7vs3 patients) and abdominal pain (10vs8 patients) occurred more with dexamethasone sodium phosphate solution than dexamethasone elixir. CONCLUSIONS: Dexamethasone sodium phosphate solution was the most palatable preparation. Prednisolone base tablets were rated least palatable and were least well tolerated. Palatability scores improved with each dose taken.

Systematic Review of the Toxicity of Long-Course Oral Corticosteroids in Children.

BACKGROUND: Long courses of oral corticosteroids are commonly used in children in the management of chronic conditions. Various adverse drug reactions (ADRs) are known to occur with their use. This systematic review aimed to identify the most common and serious ADRs and to determine their relative risk levels. METHODS: A literature search of Embase, Medline, International Pharmaceutical Abstracts, CINAHL, Cochrane Library and PubMed was performed with no language restrictions in order to identify studies where oral corticosteroids were administered to patients aged 28 days to 18 years of age for at least 15 days of treatment. Each database was searched from their earliest dates to January 2016. All studies providing clear information on ADRs were included. RESULTS: One hundred and one studies including 33 prospective cohort studies; 21 randomised controlled trials; 21 case series and 26 case reports met the inclusion criteria. These involved 6817 children and reported 4321 ADRs. The three ADRs experienced by the highest number of patients were weight gain, growth retardation and Cushingoid features with respective incidence rates of 21.1%, 18.1% and 19.4% of patients assessed for these ADRs. 21.5% of patients measured showed decreased bone density and 0.8% of patients showed osteoporosis. Biochemical HPA axis suppression was detected in 269 of 487 patients where it was measured. Infection was the most serious ADR, with twenty one deaths. Varicella zoster was the most frequent infection (9 deaths). CONCLUSIONS: Weight gain, growth retardation and Cushingoid features were the most frequent ADRs seen when long-course oral corticosteroids were given to children. Increased susceptibility to infection was the most serious ADR.

TOLERABILITY OF PREDNISOLONE AND DEXAMETHASONE IN CHILDREN IN SAUDI ARABIA.

BACKGROUND: Corticosteroids are used to treat a variety of medical conditions including acute asthma and croup where they are often given in short-courses. Epidemiological studies in Saudi Arabia show an increasing prevalence of respiratory diseases such as asthma in the past three decades.1 This study aimed to evaluate the tolerability and palatability of oral prednisolone and dexamethasone in children in Saudi Arabia. Both drugs are available in different formulations from different pharmaceutical companies. METHODS: Prospective observational and interview study. The palatability of the oral corticosteroids was evaluated by asking children and their parent's opinions of the taste and acceptability of the medication soon after drug administration. Children were asked to point at the appropriate face on a 10-cm visual analogue scale depicting five degrees of pleasure: 1 'dislike very much, 2 'dislike a little', 3 'not sure', 4 'like a little' and 5 'like very much'.2 The tolerability of the drugs, in particular nausea, vomiting and abdominal pain was also evaluated by direct questioning of the parent/patients after each drug administration, and at the end of the course. Data was collected over three months, February to April 2015. Patients aged 2-18 years with any condition being treated with oral prednisolone or dexamethasone in hospital were approached to participate. RESULTS: 122 patients (89 with asthma and 33 with croup) age range 2-11 years (mean=4.3) were recruited. 52 patients were given prednisolone base tablets, 37 patients were given prednisolone sodium phosphate syrup and 33 patients dexamethasone oral solution.The palatability score was lowest for the prednisolone base tablet (Mean rating=1.12), (prednisolone sodium phosphate group, Mean=1.62, 95% CI -0.75, -0.26; P=0.000001) (dexamethasone group, Mean=1.97, 95% CI -1.11, -0.6; P=0.000001). Dexamethasone was rated the most palatable (prednisolone sodium phosphate, 95% CI 0.08, 0.62; P=0.012). Nausea and vomiting occurred only in patients given prednisolone base tablets (24 and five patients respectively). Both were statistically more frequent when compared with the prednisolone sodium phosphate group (only four patients had nausea) (95% CI 0.19, 0.52; P=0.000001 and 95% CI 0.1, 0.18; P=0.024 respectively). In the dexamethasone group only two patients had nausea. Abdominal pain was reported in 13 patients given prednisolone sodium phosphate syrup compared to eight patients in the prednisolone tablet group (95% CI 0.02, 0.38; P=0.032). In the dexamethasone group eight patients had abdominal pain. CONCLUSIONS: Dexamethasone was the most palatable preparation though it did cause abdominal pain in nearly one quarter of patients. Prednisolone base tablets were rated the least palatable preparation and were also the least well tolerated.

LONG-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN.

BACKGROUND: Long courses of oral corticosteroids are commonly used in children in the management of conditions such as nephrotic syndrome, leukaemia, asthma and others. Various adverse drug reactions (ADRs) are known to occur with their use. This systematic review aimed to identify the most common and serious ADRs and to determine their relative risk levels. METHODS: A literature search of several databases; Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for at least 15 days of treatment. Each database was searched from their earliest dates to March 2014. All types of studies that provided clear information on ADRs were included. RESULTS: 91 relevant studies were found from 27 countries. These studies represented a total of 6653 children and contained reports of 4124 ADRs, the majority in patients with leukaemia, haemangioma and asthma. Oral prednisolone was the most commonly prescribed corticosteroid (74% of patients). The three most frequent ADRs were weight gain, Cushingoid features and growth retardation. The incidence rates of patients with these three ADRs were 22.4%, 20.6% and 18.9%, respectively. Increased susceptibility to infection was the most serious ADR. 24 children died from infections, ten from varicella zoster and the others from different microorganisms. CONCLUSIONS: Weight gain, Cushingoid features and growth retardation were the most frequent ADRs seen when long-course oral corticosteroids were given to children. In addition, increased susceptibility to infection was the most common cause of mortality.

INTERVENTIONS MADE BY UK PHARMACISTS TO MINIMISE RISK FROM PAEDIATRIC PRESCRIBING ERRORS.

BACKGROUND: Prescribing errors have the potential to adversely affect the safe pharmacological treatment of patients of all ages. The multi-centre General Medical Council commissioned 'EQUIP' study assessed the prevalence and nature of prescribing errors and found a mean rate of errors in 8.9% of medication orders.1 Paediatric data was not however analysed separately. Errors have been estimated to cause harm in paediatric patients three times more often than in adults.2 Clinical pharmacists play a role in identifying prescribing errors and minimising harm but this role has not been explored in detail in children in the UK. OBJECTIVES: To evaluate the prevalence and nature of prescribing errors and the role of hospital pharmacists in identifying and reducing risk in neonatal and paediatric patients. METHODS: Data collection sites were identified through the Neonatal and Paediatric Pharmacists Group by an email asking for volunteer centres. Clinical pharmacists working in these hospitals were asked to document prescribing errors in inpatient medication orders identified as part of their routine practice using a data collection form adapted from the EQUIP study1. A variety of hospital settings were aimed for.Data was collected monthly on six separate weekdays in most of the participating hospitals in 2013. Data was entered on to a SPSS database for collation and analysis.Classification of error type and potential severity was done using the EQUIP study categories1. Drugs were categorised according to the British National Formulary for Children3 and patient's ages were grouped according to the International Conference of Harmonisation guidelines.4 RESULTS: Thirteen hospitals (eight specialist children's and five general teaching hospitals) from across the UK agreed to participate. Pharmacists checked 11,941 prescriptions written for 3,330 patients and identified 1,039 errors: an overall rate of 8.7% of medication orders with 20.6% of all patients having a prescribing error.Overdose was found to be the most common error followed by incorrect or missing administration times and underdose. This was in contrast to the EQUIP study where omission errors were most common. Specialist trainees/trust grade fixed term specialty training appointments (FTSTAs) made the majority of errors; however this was in proportion with the number of prescriptions which they wrote. Antibacterial and analgesic drugs were the most common classes associated with errors and the oral route was the most common route involved.70% errors were classified as minor, though 25% were considered significant, 5.4% serious and 0.22% (two errors) potentially lethal. Five patients were stated to have experienced harm.39.6% of errors occurred during the patient's hospital stay followed by 35% errors occurring on admission. CONCLUSION: Prescribing errors occurred at a similar rate as in adult patients 1 but the most common type of errors was different with dosing errors most common in children. Clinical pharmacists' interventions play an important role in identifying and minimising harm from prescribing errors.

Systematic review of the toxicity of short-course oral corticosteroids in children.

BACKGROUND: Short-course oral corticosteroids are commonly used in children but are known to be associated with adverse drug reactions (ADRs). This review aimed to identify the most common and serious ADRs and to determine their relative risk levels. METHODS: A literature search of EMBASE, MEDLINE, International Pharmaceutical Abstracts, CINAHL, Cochrane Library and PubMed was performed with no language restrictions to identify studies in which oral corticosteroids were administered to patients aged 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All studies providing clear information on ADRs were included. RESULTS: Thirty-eight studies including 22 randomised controlled trials (RCTs) met the inclusion criteria. The studies involved a total of 3200 children in whom 850 ADRs were reported. The three most frequent ADRs were vomiting, behavioural changes and sleep disturbance, with respective incidence rates of 5.4%, 4.7% and 4.3% of patients assessed for these ADRs. Infection was one of the most serious ADRs; one child died after contracting varicella zoster. When measured, 144 of 369 patients showed increased blood pressure; 21 of 75 patients showed weight gain; and biochemical hypothalamic-pituitary-adrenal axis suppression was detected in 43 of 53 patients. CONCLUSIONS: Vomiting, behavioural changes and sleep disturbance were the most frequent ADRs seen when short-course oral corticosteroids were given to children. Increased susceptibility to infection was the most serious ADR. TRIAL REGISTRATION NUMBER: CRD42014008774. By PROSPERO International prospective register of systematic reviews.

Nurses' knowledge about the double-checking process for medicines administration.

This study aimed to evaluate nurses' knowledge, perceptions and opinions of double-checking medication administration in a UK children's hospital. Of 119 questionnaires distributed, 48 were returned. Only 30 respondents had seen a written version of the hospital double-checking policy. More than half stated that they had not received formal training in double-checking medications. Of 35 nurses providing a definition of double-checking, one gave a response that reflected hospital policy. Most respondents thought that staffing, workloads and interruptions affected adherence to double-checking; 15 reported that double-checking was easier to do at night; and the results suggested that lack of knowledge and of clear guidelines contributed to medication errors.

Paediatric nurses' adherence to the double-checking process during medication administration in a children's hospital: an observational study.

AIM: To evaluate how closely double-checking policies are followed by nurses in paediatric areas and also to identify the types, frequency and rates of medication administration errors that occur despite the double-checking process. BACKGROUND: Double-checking by two nurses is an intervention used in many UK hospitals to prevent or reduce medication administration errors. There is, however, insufficient evidence to either support or refute the practice of double-checking in terms of medication error risk reduction. DESIGN: Prospective observational study. METHODS: This was a prospective observational study of paediatric nurses' adherence to the double-checking process for medication administration from April-July 2012. RESULTS: Drug dose administration events (n = 2000) were observed. Independent drug dose calculation, rate of administering intravenous bolus drugs and labelling of flush syringes were the steps with lowest adherence rates. Drug dose calculation was only double-checked independently in 591 (30%) drug administrations. There was a statistically significant difference in nurses' adherence rate to the double-checking steps between weekdays and weekends in nine of the 15 evaluated steps. Medication administration errors (n = 191) or deviations from policy were observed, at a rate of 9·6% of drug administrations. These included 64 drug doses, which were left for parents to administer without nurse observation. CONCLUSION: There was variation between paediatric nurses' adherence to double-checking steps during medication administration. The most frequent type of administration errors or deviation from policy involved the medicine being given to the parents to administer to the child when the nurse was not present.

A prospective study to assess the palatability of analgesic medicines in children.

AIM: This study examined children's opinions on the taste of three analgesic medicines: paracetamol, ibuprofen and codeine. BACKGROUND: Many medicines for children are unpleasant and unacceptable. Research has shown that children's taste preferences differ to adults, in whom palatability is often tested. Little British research exists on children's opinions on the palatability of medicines. This study aimed to address this gap in knowledge. DESIGN: Prospective observational study. METHODS: Between May-September 2008, hospital inpatients aged 5-16 years rated the taste of required analgesics on a 100-mm visual analogue scale. This incorporated a 5-point facial hedonic scale. They were also asked their favourite flavour and colour for a medicine. RESULTS: A total of 159 children took part. Eighty-five males (53·5%) and 74 females (46·5%). The median age was 8 years (Inter-quartile range 6-11). The taste of ibuprofen was significantly preferred to paracetamol or codeine. Significant differences were observed depending if the medicine rated was taken first or second (for example pre-medication with paracetamol and ibuprofen). Younger children (5-8 years) were more likely to choose the extremes of the scale when grading than older children were. Preferred flavours on questioning were strawberry 44% and banana 17%. Favourite colours were pink 25·8% and red 20·8%, with girls more likely to choose pink and boys blue. CONCLUSION: Ibuprofen was the most palatable analgesic medicine tested. Children reported they preferred fruit flavours and colour was sex dependent. Nurses when administering two medicines together should consider giving the least palatable first, for example paracetamol before ibuprofen for pre-medication.

Medication errors in the Middle East countries: a systematic review of the literature.

BACKGROUND: Medication errors are a significant global concern and can cause serious medical consequences for patients. Little is known about medication errors in Middle Eastern countries. The objectives of this systematic review were to review studies of the incidence and types of medication errors in Middle Eastern countries and to identify the main contributory factors involved. METHODS: A systematic review of the literature related to medication errors in Middle Eastern countries was conducted in October 2011 using the following databases: Embase, Medline, Pubmed, the British Nursing Index and the Cumulative Index to Nursing & Allied Health Literature. The search strategy included all ages and languages. Inclusion criteria were that the studies assessed or discussed the incidence of medication errors and contributory factors to medication errors during the medication treatment process in adults or in children. RESULTS: Forty-five studies from 10 of the 15 Middle Eastern countries met the inclusion criteria. Nine (20 %) studies focused on medication errors in paediatric patients. Twenty-one focused on prescribing errors, 11 measured administration errors, 12 were interventional studies and one assessed transcribing errors. Dispensing and documentation errors were inadequately evaluated. Error rates varied from 7.1 % to 90.5 % for prescribing and from 9.4 % to 80 % for administration. The most common types of prescribing errors reported were incorrect dose (with an incidence rate from 0.15 % to 34.8 % of prescriptions), wrong frequency and wrong strength. Computerised physician rder entry and clinical pharmacist input were the main interventions evaluated. Poor knowledge of medicines was identified as a contributory factor for errors by both doctors (prescribers) and nurses (when administering drugs). Most studies did not assess the clinical severity of the medication errors. CONCLUSION: Studies related to medication errors in the Middle Eastern countries were relatively few in number and of poor quality. Educational programmes on drug therapy for doctors and nurses are urgently needed.

Use of checking systems in medicines administration with children and young people.

This study aimed to establish which policies are in place for checking medication administration in UK children's units and to discuss evidence to support the use of different checking processes. It involved a questionnaire survey (n=105) in 69 UK hospitals of children's nurses and pharmacists. In the hospitals surveyed, most administrations of oral and intravenous medications were checked by two registered children's nurses. Evidence suggests a role for single and double checking depending on risk assessment. Robust research is needed to further evaluate these processes.

Double checking the administration of medicines: what is the evidence? A systematic review.

OBJECTIVE: To evaluate the evidence for double checking the administration of medicines. DESIGN: A systematic search of six electronic databases-Embase, Medline, British Nursing Index and Archive, CINAHL, National electronic library for Medicines (NeLM) and PsycINFO-for all articles describing double checking of medication and dose calculation, for either dispensing or administration in both adults and children up to and including October 2010. RESULTS: Sixteen articles met the inclusion criteria. There were only three quantitative studies. Only one of these was a randomised controlled clinical trial in a clinical setting. This study showed a statistically significant reduction in the medication error rate from 2.98 (95% CI 2.45 to 3.51) to 2.12 (95% CI 1.69 to 2.55) per 1000 medications administered with double checking. One study reported a reduction in dispensing errors, by a hospital pharmacy, from 9.8 to 6 per year following the introduction of double checking. The majority of the studies were qualitative and involved interviews, focus groups and questionnaires. CONCLUSION: There is insufficient evidence to either support or refute the practice of double checking the administration of medicines. Clinical trials are needed to establish whether double checking medicines are effective in reducing medication errors.

Association between licence status and medication errors.

BACKGROUND AND AIMS: Unlicensed and off label drug use in children is common and leads to well-recognised problems. This study aimed to determine whether a relationship exists between medication errors and licence status. METHODS: Reports of errors in a UK children's hospital from 2004 to 2006 were analysed in terms of licence status and degree of harm and compared to the incidence of unlicensed and off label drug use in the hospital. RESULTS: 20 of 158 (13%) errors were considered to have caused moderate harm and 12 of these involved unlicensed/off label drugs. 138 (87%) caused no or low harm. None caused severe harm. Unlicensed drug usage was significantly more likely to be associated with errors than licensed use in both children and neonates. CONCLUSION: Unlicensed drug use appears to be associated with medication errors in neonates and children. Medication errors causing moderate harm were significantly more likely to be associated with both unlicensed and off label than licensed drugs.

Medulloblastoma in childhood: revisiting intrathecal therapy in infants and children.

INTRODUCTION: Intrathecal chemotherapy is being explored in medulloblastoma in pre-school children as part of brain-sparing strategies and as an alternative to unacceptably neurotoxic cranio-spinal radiotherapy. The range of drugs suitable for this route of administration is restricted by the lack of research evidence of pharmacological suitability and efficacy of other drugs in medulloblastoma. METHODS: Ideal clinical, biological, physicochemical and pharmaceutical properties for intrathecal administration were defined through literature review of pharmaceutical texts, Medline, Embase and consulting the manufacturers. A total of 126 chemotherapy agents were assessed against these criteria by searching the academic domain of pharmaceutical texts, computer databases and consultation with manufacturers. RESULTS: Of the 126 candidate drugs, 99 were rejected because of documentation of their irritant nature, neurotoxicity and requirement for hepatic activation in standard pharmaceutical texts. Fifty were rejected for a single identifiable reason including, neurotoxicity (n = 24), irritant (n = 15), needs enzyme activation (n = 5), clinical evidence of intrathecal neurotoxicity (n = 4) and no evidence of tumour-specific efficacy (n = 2). Where two reasons were cited the justifications were: neurotoxic and irritant (n = 3) and needs activation and systemic administration results in equivalent concentration (n = 1). Twenty-seven drugs remained of which 12 were selected as eligible for further clinical investigation, and 15 were selected for further pre-clinical investigation. CONCLUSIONS: The pre-determined criteria were not applicable, in their entirety, in the majority of drugs, due to lack of information in the academic domain, emphasising the importance of a more open approach for sharing basic drug information. The prioritised list of 12 candidate drugs for clinical trial and 15 for pre-clinical investigation justify that a concerted research effort in this area of practice is made.

Interventions to reduce dosing errors in children: a systematic review of the literature.

Children are a particularly challenging group of patients when trying to ensure the safe use of medicines. The increased need for calculations, dilutions and manipulations of paediatric medicines, together with a need to dose on an individual patient basis using age, gestational age, weight and surface area, means that they are more prone to medication errors at each stage of the medicines management process. It is already known that dose calculation errors are the most common type of medication error in neonatal and paediatric patients. Interventions to reduce the risk of dose calculation errors are therefore urgently needed. A systematic literature review was conducted to identify published articles reporting interventions; 28 studies were found to be relevant. The main interventions found were computerised physician order entry (CPOE) and computer-aided prescribing. Most CPOE and computer-aided prescribing studies showed some degree of reduction in medication errors, with some claiming no errors occurring after implementation of the intervention. However, one study showed a significant increase in mortality after the implementation of CPOE. Further research is needed to investigate outcomes such as mortality and economics. Unit dose dispensing systems and educational/risk management programmes were also shown to reduce medication errors in children. Although it is suggested that 'smart' intravenous pumps can potentially reduce infusion errors in children, there is insufficient information to draw a conclusion because of a lack of research. Most interventions identified were US based, and since medicine management processes are currently different in different countries, there is a need to interpret the information carefully when considering implementing interventions elsewhere.

The use of unlicensed and off-label medicines in the neonate.

The use of unlicensed and off-label medicines in neonates in intensive care is common and widespread. Up to 93% of babies receive at least one unlicensed or off-label medicine during their stay in intensive care. Such practice is an essential part of their care and should be done based on the best evidence available. However, problems arise - on an every-day basis - because of the lack of appropriate information and licensed medicine formulations for neonates. These problems include the selection of appropriate medicine and dose, administration and the increased risk of medication errors. Initiatives to improve the situation are underway in the US and are proposed in Europe. However, more urgent action is required to stop these babies continuing to be deprived of their basic human rights to safe, effective and high-quality therapy.