Paediatric Pharmacists Group Research Articles

Pharmacy group publishes first list of standard IV infusion concentrations for use in children in the UK

A proposal to standardise paediatric intravenous (IV) infusions across the UK has been published by the Neonatal & Paediatric Pharmacists Group (NPPG). The report, which is supported by the joint Royal College of Paediatrics and Child Health (RCPCH)/NPPG standing committee on medicines, offers the first list of published standard IV infusion concentrations, for use in […]

P42 All-in-one parenteral nutrition: a national survey

AimsTo gather details about the current usage of All-in-One (AIO) Parenteral Nutrition (PN) for children in the UK, reasons that organisations have switched to using AIO PN and benefits that occurred. For organisations not using AIO PN, the aim is to find out if they have plans to use it in the future and why/not. The ultimate aim is to determine whether AIO PN should be used locally and/or nationally via standardised paediatric PN to improve patient safety.BackgroundConventional split-phase PN is subject to ‘rate switch’ errors when lipid is infused at the rate intended for aqueous PN and vice versa. A 2017 alert from NHS Improvement (NHSI) highlighted that serious adverse effects have occurred due to overly-rapid infusion of PN in babies and children. Using AIO PN eliminates the risk of rate switch errors although there is scant evidence in literature of enhanced safety. A project group has been developing national standardised paediatric PN, with work ongoing. Local rate switch incidents, the NHSI alert and a desire to provide appropriate national standardised PN are the drivers behind this survey.MethodsA survey monkey® was designed and circulated to members of the Neonatal and Paediatric Pharmacists Group (NPPG) via email. Members were asked to respond on behalf of their organisation if they provided PN to babies or children. The survey included 10 questions/fields, with discrete choices such as yes/no/don’t know or ‘select all that apply’.Results51 responses were received from 48 organisations. Close to 50% were using AIO PN for inpatients. Organisations using AIO PN: 70% used both AIO and split-phase PN. AIO PN was used mainly for larger children: adolescents/children >40 kg (64% of organisations); children 30–39.9 kg (60%); and children 20–29.9 kg (48%). Nurse preference/ease of administration (45%), addressing a local safety concern (25%) and responding to the NHSI safety alert (21%) were the most common reasons for using AIO PN. AIO PN was perceived as having a positive impact including: improved patient safety (42% of organisations); improved local aseptic unit capacity (38%); and improved nurse satisfaction (29%). Methods of providing AIO PN included: locally prepared-licensed multi-chamber bag with additions (54%); externally prepared-as bespoke/scratch (39%); licensed multi-chamber bag without additions (39%); externally prepared-standard bag (12%); externally prepared-licensed multi-chamber bag with additions (12%); locally prepared-as bespoke/scratch either using a compounder or via other method (8% each). Organisations not using AIO PN: 43% of organisations were not planning to use AIO PN or didn’t know and 15% planned to start in the future. 42% selected ‘other’ and gave comments, primarily relating to avoiding AIO PN for neonates, e.g. need to use neonatal network PN (split-phase) or prefer flexibility to stop lipid in case of adverse effects. Eleven organisations answered, ‘Why are you thinking of using AIO PN?’ – examples included releasing aseptic capacity, reducing administration errors/improving safety and the long shelf life of triple-chamber AIO bags.ConclusionAIO PN appears to be an appropriate and safe for local use and should be taken into account in national standard paediatric PN formulation design where practicable.

P66 Standardising strengths of unlicensed medicines in a large London hospital trust

BackgroundA UK national position statement on standardised strengths of unlicensed liquid medicines recommend that when children require unlicensed liquid medications, they should receive the recommended strength. By standardising strengths of these medicines, the risk of errors being made in the doses given to children will be reduced and prevent accidental under and overdoses.1 Our Trust has 4 hospital sites since merging in 2012, we found the process of switching to a standard strength far from simple.MethodsThe strengths of unlicensed liquid medicines listed in the position statement available on the pharmacy dispensing system (JAC) were identified, along with the speciality users. Pharmacy and clinical leads were consulted for agreement to switching to the standardised strengths. Pharmacy procurement identified new products in standardised strengths and products were reviewed for suitability by paediatric pharmacist. A cost impact analysis was carried out. Communication was sent to stakeholders including, doctors, nurses, pharmacy and primary care.Results and DiscussionWe found the standardised strengths of azathioprine, clonazepam, ethambutol, isoniazid, melatonin, omeprazole, phenobarbitone and pyrazinamide strengths were on formulary. Clopidogrel, hydrocortisone, sertraline and tacrolimus liquids are not used. Different strengths of the listed unlicensed liquid medicines were used by different sites and specialties. Lead speciality pharmacists agreed with the standardisation. We identified use of unlicensed products where licensed products are available (sildenafil 20 mg/5 mL and furosemide 5 mg/5 mL). We added the use of these items to our review. We were not able to agree on a single standard strength for some items; the neonatal intensive care unit (NICU) have babies under 500 g who may require furosemide, spironolactone and sildenafil in doses that measure less than 0.1 mL using the recommended strengths. This volume is deemed less than satisfactory to be measured safely1. It has been agreed with the neonatal lead pharmacist that additional strengths of the sildenafil (unlicensed 20 mg/5 mL), spironolactone (unlicensed 10 mg/5 mL) and furosemide (20 mg/5 mL) be available for inpatient NICU use only. The potential for patients to be discharged on the non-standard strength is reduced by specifying ‘Not for discharge - inpatient use only’ on the pharmacy system as well as having them only as NICU stock from medicines distribution. Patients admitted on other strengths will be switched (with consent); to minimise risk pharmacists will ensure carers are aware of the change & correct dose volume to administer and endorse TTAs noting the change in concentration for the GP. Primary care have been engaged with the switch and invited the consultant pharmacist to discuss this at the interface meeting. We were not able to source the recommended midazolam 10 mg/5 mL. The switch to chloral hydrate to 1 g/5 mL was calculated to have a significant cost pressure therefore it was agreed that that we would not change from chloral hydrate 500 mg/5 mL at this time as it is mainly used in the in-patient setting within our Trust. Based on current usage there is an estimated cost saving of over £5 k based on the switch of sodium chloride, sildenafil, furosemide and spironolactone. The impact will be reviewed in 6 months.ConclusionA successful switch requires a team approach but will benefit patient safety and save money.ReferenceThe Neonatal and Paediatric Pharmacists Group (NPPG) and Royal College of Paediatric and Child Health (RCPCH). Position statement 18–01 Using Standardised Strengths of Unlicensed Liquid Medicines in Children. Version 2. May 2019.

P09 A survey of the NPPG group concerning medication administration problems among children and young people aged 0 to 18 years old

AimTo identify issues encountered by pharmacy healthcare professionals with regards to problems that they have experienced, complaints received, queries and feedback by the patients or parents or caregivers in terms of medication administration for children and young people aged 0 to18 years old.MethodAn online survey using the Online Surveys tool was devised to obtain healthcare professionals’ perspective regarding medication administration problems encountered by parents, caregivers or paediatric patients when administering or taking their medication at home. The survey was sent to the members of the Neonatal and Paediatric Pharmacists Group (NPPG), who represent different geographical areas within the UK and further afield. Informed consent was obtained from participants. This study was reviewed and approved by the Life and Health Sciences Ethics Committee, Aston University.Results37 pharmacists and 1 technician completed the survey. The majority of the respondents 23/38 were currently practicing in England, with 6/38 respondents being registered pharmacists outside the UK, 1/38 was practicing in Northern Ireland, 3/38 within Scotland and 4/38 were practicing in Wales. 71.1% of the respondents strongly agreed that parents or caregivers require further training when it comes to medication delivery to their children. In addition, when asked about their concerns regarding prescribed medication to children aged between 0 to18 years old, respondents expressed a different level of concern regarding each age group. Regarding neonates, the main concern was the suitability of the prescribed formulation and the ability of the parents to accurately measure and administered a low dose volume. In contrast, for children aged between 28 days to 12 years, the common concerns were associated with palatability, which will further reflect upon child compliance and the parent or caregiver’s ability to understand medication instructions and administration. Finally, for older aged children, adherence was a common concern. Furthermore, liquid formulations (suspensions (60.5%), solutions (55.3%) and injections (44.7%)) were predominantly used among children aged 0 to 18 years old within both in and outpatients setting. Overall, the majority of the respondents expressed that counselling time between the patient and pharmacists and the need to provide further training and educational material to parents and young people is an important issue to improve understating in regards medication use.ConclusionThe findings suggest that medication administration problems occur frequently among paediatric patients, and the nature of these problems varies among each age group. Medication training for both parents and young people could be a key factor to help reduce this problem. Future research is needed to investigate and gain insight into personal experiences with medication use and administration from a parent and/or young person’s perspective. This will help to highlight the current problem in the UK and further develop potential interventions to reduce medication administration errors by parents of children aged 0 to 16 years old and by young people up to the age of 18 years.

P20 Evaluation of analgesic doses prescribed postoperatively for overweight and obese children

AimIn England, 17% of children aged 2–15 are considered obese and a further 13% overweight.1 Physiological changes associated with obesity affect pharmacokinetic and pharmacodynamic parameters which may necessitate paediatric drug dose alteration although few guidelines exist to support this in clinical practice. This study aimed to:determine the proportion of patients at a large paediatric hospital prescribed analgesics postoperatively who are obese or overweightevaluate how analgesics are currently prescribed for these overweight and obese patientsdetermine whether doses are altered according to published recommendationsdetermine whether clinical outcomes differ for overweight or obese children compared to non-overweight childrenMethodPostoperative paediatric inpatients aged 2–15 prescribed paracetamol, ibuprofen or morphine (or combination thereof) were included in the six-week prospective study. Demographic (age, weight, height, gender), prescription (drug name, dose, route, frequency) and clinical (surgical specialty, pain scores, paediatric early warning scores) information was collected from medical notes and drug charts. Patients with significant organ impairment or requiring intensive care were excluded.Body-mass-index centile (BMI-C) was calculated for each child using a validated web-based calculator and used to classify patients as non-overweight (BMI-C <91), overweight (BMI-C ≥91 and <98) or obese (BMI-C ≥98). Prescribed paracetamol and morphine doses were evaluated against patients’ total body weight (TBW) and ideal body weight (IBW) and ibuprofen doses were evaluated against patients’ TBW and lean body mass (LBM)2 according to published dosing adjustment recommendations2 3 and compared against formulary dosing standards.4 Clinical outcome data was used to evaluate pain control and clinical status.ResultsBMI-C was calculated for 198 postoperative paediatric inpatients, and of these 142 (72%) were non-overweight, 27 (13.5%) were overweight and 29 (14.5%) were obese. Complete prescription and clinical data were available for 44 non-overweight, 22 overweight and 23 obese patients who were subjected to further analysis. Formulary dosing standards were 15 mg/kg for paracetamol, 5 mg/kg for ibuprofen and 0.1–0.2 mg/kg for morphine.[4] Mean postoperative oral paracetamol doses were 15.0 mg/TBW, 18.1 mg/IBW and 20.6 mg/IBW for non-overweight (n=43), overweight (n=22) and obese (n=23) patients respectively. Mean postoperative oral ibuprofen doses were 5.0 mg/TBW, 5.7 mg/LBM and 6.2 mg/LBM for non-overweight (n=37), overweight (n=16) and obese (n=21) patients respectively. Mean postoperative oral morphine doses were 0.14 mg/TBW, 0.17 mg/IBW and 0.18 mg/IBW for non-overweight (n=33), overweight (n=13) and obese (n=16) patients respectively. There was no significant difference in pain scores or paediatric early warning scores at 0-, 4- 12- and 24-hours post-surgery between the three cohorts.ConclusionThe proportion of patients in this study who were overweight or obese aligned with national prevalence data.[1] Children who were overweight or obese received higher doses of paracetamol, ibuprofen and morphine compared to non-overweight children, and doses of paracetamol and ibuprofen were greater than formulary dosing standards. This suggests that doses for obese or overweight children are not adequately adjusted according to IBW or LBM which may result in drug toxicity. Guidance for prescribers is need to aid identification of patients who are overweight or obese and to guide appropriate dose adjustment.ReferencesNatCen Social Research. Health Survey for England 2017: Adult and child overweight and obesity. National Statistics & NHS Digital. https://files.digital.nhs.uk/3F/6971DC/HSE17-Adult-Child-BMI-rep.pdf [accessed 4 April 2019]UK Medicines Information & Neonatal and Paediatric Pharmacists Group. How should medicines be dosed in children who are obese? 2018 https://www.sps.nhs.uk/articles/how-should-medicines-be-dosed-in-children-who-are-obese/ [accessed 20 December 2018]Sydney Children’s Hospital. Drug Dosing for Overweight and Obese Patients. 2013. http://www.schn.health.nsw.gov.au/_policies/pdf/2013-7034.pdf [accessed 15 November 2018]Evelina London Children’s Hospital. Paediatric Formulary. http://cms.ubqo.com/public/d2595446-ce3c-47ff-9dcc-63167d9f4b80 [accessed 26 December 2018].

P59 Assessing medicines for safe use in paediatrics

AimThis service review aimed to reassess and upgrade the ‘New Products Assessment Form’ and to develop an assessment tool in line with European regulations governing paediatric medicines. Many medicinal products routinely used to treat the paediatric population have not been studied or authorised for paediatric use, which means there is widespread unlicensed and ‘off-label’ use of medicines. Medicines deemed safe in adult formulations may not be appropriate for paediatric patients. Medicines must therefore be carefully selected based on agreed criteria including, but not limited to: licensing, excipients, administration, labelling, similarity to other products, safety and handling.MethodA literature review was conducted. Guidance, information, and advice was sought from other healthcare institutions, and European guidelines and directives informing current practise around excipients in paediatric medicines. Pharmacy colleagues were consulted during the development of the tool, and an accessible assessment tool was completed for use in a tertiary paediatric hospital.1–4ResultsThis is the first comprehensive ‘New Products Assessment Form’ in the hospital which complies with the European Medicines Agency (EMA) directives governing excipients in paediatric medicines. The document highlights clearly potential issues and risks associated with product excipients, licensing status, warning label guidance and allows for recording of rationale for the selection of medicines. The ‘New Products Assessment Form’ is intended to highlight potential issues associated with excipients and their associated acceptable daily intake (ADI), but it will also highlight other risks associated with medicines used in paediatrics e.g. inadequate labelling, translation requirements for foreign products, sound-alike/look-alike products, safety and handling, and others.ConclusionThis revised assessment tool has been approved for use in the hospital pharmacy. It will be made available in hospital and community pharmacies on request. Use of the tool should be monitored and audited.ReferencesAnnex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). https://www.ema.europa.eu/en/documents/scientific-guideline/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human_en.pdf. NPPG Neonatal and Paediatric Pharmacists Group Newsletter No 61 Autumn 2016. Excipients in medicines for children. http://nppg.org.uk/wp-content/uploads/2017/04/NPPG-61.pdfQuestions and Answers on Ethanol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00) https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-ethanol-context-revision-guideline-excipients-label-package-leaflet-medicinal_en.pdfEMA. Guideline on pharmaceutical development of medicines for paediatric use.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf

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

BackgroundPrescribing 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...

BENCHMARKING NEONATAL PHARMACISTS TIME IN THE UNITED KINGDOM

Aim To benchmark current levels of Pharmacist staffing on Neonatal Units in the UK and compare this to the time per cot defined in ‘British Association of Perinatal Medicine (BAPM) Service Standards for Hospital9s Providing Neonatal Care’ and the Pharmacist provision statements contained in ‘Department of Health9s toolkit for High Quality Neonatal services 2009’.1 2 Method a short online Survey monkey survey was developed and sent via the Neonatal and Paediatric Pharmacists Group (NPPG) email network to all NPPG registered pharmacists. The questions were designed to ascertain workload, Pharmacist time, funding of time and inclusion of neonatal unit work within job descriptions. The Pharmacists were then asked to compare this information against the Recommended Pharmacist provision as outlined in the British Association Perinatal Medicines Service Standards.1 Results 40 units responded to the survey covering 974 neonatal beds. All bar one result was from the UK leaving a total of 39 units for analysis The average amount of Neonatal Pharmacists time spent on the wards is 6.7 minutes per cot. This is broken down as follows Level 1 units n=3 average time/cot 3.3 min Level 2 units n=15 average time/cot 5.7 min Level 3 units (all) n=21 average time/cot 7.9 min Level 3 units with surgery n=8 average time/cot 6.7 min Level 3 units without surgery n=13 average time/cot 8 min The number of units that complied with BAPM standards for neonatal staff time was 6 (15%). All of these were level 3 units. 12 (31%) of Pharmacists felt they have enough time to undertake the necessary duties even though 7 (18%) we9re not compliant with BAPM time. Of these 12 the time varied between 5–9 mins per cot and covered all unit levels. 28 (72%) responders did not feel that they had sufficient time to do the neonatal work. 20 (51%) of Pharmacists providing care to Neonatal patients stated did not have their role defined in their job description. Conclusion Only (15%) of neonatal units are compliant with the British Association Perinatal Medicines Service Standards for pharmacist9s time per cot, although a further 18% with cot time less than the BAPM standards were happy with the available time they have to provide care. It is clear that the current level of funding assigned within hospitals for the pharmaceutical care of neonates is still low with many staff diverting funding for other posts or areas to provide this. I would encourage all Trusts to review their current provision of Pharmacist time on their neonatal unit against the BAPM standards. I would also encourage them to ensure that their neonatal unit Pharmacists duties are clearly defined within their job description, to ensure compliance with The Department of Health9s Best Practice Standards.

G308(P) Parents think that ‘medicines for children’ reaches nice places:

Background Whilst only 20% of content discussed in a consultation is retained, it’s improved by giving additional written information. Patients are able to use written leaflets to consolidate their knowledge away from the stressful environment of a patient-doctor discussion. Such written information may increase treatment compliance and concordance. The ‘Medicines for Children’ website is designed to provide practical and reliable advice for families about giving medicine to their children. It has a variety of leaflets, videos and web-based information on over 200 children’s medications. It’s a partnership between the Royal College of Paediatrics and Child Health, the Neonatal and Paediatric Pharmacists Group and WellChild; a charity for parents and carers. Objective To evaluate the ‘Medicines for Children’ website and information sheets, against the NICE quality standard 15; Understanding Treatment Options and NICE Medicines adherence guideline 76; involving patients in decision about prescribed medicines. Methods A questionnaire was designed against the specific criteria set out in NICE quality standard 15 and clinical guideline 76. Questions focused on the layout, language and content of the leaflet, particularly information regarding the treatment risks and benefits. Data was collected from a convenience sample of parents attending children’s outpatient clinics. Qualitative feedback was also sought. Parents were asked to read the leaflet on ‘Beclametasone inhaler for asthma prophylaxis’ and answer the questionnaire as though their child were starting on this medication. Results 106 parents participated. 16 declined. Parents comments included: ‘clearly laid-out with simple sub-headings’, ‘written in a way that everyone can understand’. They suggested future developments should include: ‘pictures for adults with lower literacy levels’ and ‘having the leaflets in both English and Welsh.’ Conclusion Medicines for Children information leaflets fulfil NICE standards and provide high quality information about children’s medications which is highly valued by families.

G395 More and More Parents are taking their Medicines for Children

BackgroundMedicines for Children (MfC) is a joint venture between the RCPCH, NPPG (Neonatal Paediatric Pharmacists Group) and the charity Wellchild. It aims to provide accessible, unbiased high quality information for...

E-prescribing implementation in paediatrics: lessons learned

Implementing electronic prescribing (ePrescribing) in paediatrics is complex and systems may be sub-optimally designed to improve safety. Paediatric prescribing rules and clinical decision support (CDS) are required; Pharmacist involvement in...

Pediatric Pharmacy Advocacy Group International Pediatric Pharmacy and Pharmacology Symposium, 24–26 April 2009; Orlando, Florida, USA†

This milestone meeting, expertly organized by Mr David Knoppert (Scientist, Children’s Health Research Institute, Department of Pharmacy, St Joseph’s Hospital, London, ON, Canada), was the first international symposium on paediatric clinical pharmacy andpharmacology.Over 220paediatric pharmacists and clinical pharmacologists, representing more than 20 countries and all continents, were welcomed by Dr Stuart MacLeod (Department of Paediatrics, University of British Columbia, and Child & Family Research Institute, Vancouver, BC, Canada) representing the International Alliance for Better Medicines for Children (IABMC). Plenary sessions, lectures, round table discussions and workshops were given/led by an international contingent of experts. The content reflected the interdisciplinary nature of paediatric therapeutics, covering, in addition to clinical pharmacy and pharmacology, drug policy, drug safety, pharmacogenomics, drug regulation, international health, pharmacy education and pharmaceutical formulation science. The themes of the symposium were outreach, translational research and clinical practice. Within this framework, presenters and attendees examined how paediatric pharmacy and pharmacology, through international collaboration, can contribute to optimal drug therapy for the world’s children. The need for multidisciplinary networks through enhanced communication and collaboration was evident throughout the meeting; practitioners, educators and researchers from industry, government and pharmacy organizations emphasised this. Representatives included Dr Agnes Saint Raymond (European Medicines Agency [EMEA]), Ms Sara Arenas (European Society of Clinical Pharmacy [ESCP]),Dr David Hoff (American College of Clinical Pharmacy’s [ACCP] Practice and Research Network [PRN]), Dr John van den Anker (European Society for Developmental Perinatal & Paediatric Pharmacology [ESDPPP]), Dr Michael Christensen (Pediatric Pharmacy AdvocacyGroup [PPAG]),DrGeorge Giacoia (National Institutes of Health [NIH]), Dr Suzanne Hill (WHO), Dr Sharon Conroy (Neonatal and Paediatric Pharmacists Group [NPPG]) and Dr Klaus Rose (Roche). They identified specific areas to target, including (i) enhancing undergraduate and graduate training in paediatric pharmacy; (ii) developing a system for data integration and information sharing across countries; (iii) focusing on collaborative research and capacity building of researchers/ clinicians; (iv) increasing the quality of paediatric drug clinical trials in all age groups (including neonates and pregnant women) and increasing the number of multicentre trials to maximize the use of a limited pool of patients; (v) advocacy of paediatric medication issues through government and nongovernment non-profit entities and the pharmaceutical industry; (vi) focusing on formulations, unlicensed use of medications, reference sources and prescription monitoring; (vii) identifying the players (product, supply, research, use, policy, pharmacoepidemiology) and including representatives inmultidisciplinary teams; and (viii) offering knowledge to developing countries and encouraging trained paediatric clinicians to reach out to the remote and underserved. There are both many challenges and opportunities. There is a lot of enthusiasm within the sector but the workload is huge, and paediatric pharmacists and pharmacologists are underrepresented. We need to learn from past mistakes, maximize

Pediatric Pharmacy Advocacy Group International Pediatric Pharmacy and Pharmacology Symposium, 24–26 April 2009; Orlando, Florida, USA

This milestone meeting, expertly organized by Mr David Knoppert (Scientist, Children’s Health Research Institute, Department of Pharmacy, St Joseph’s Hospital, London, ON, Canada), was the first international symposium on paediatric clinical pharmacy andpharmacology.Over 220paediatric pharmacists and clinical pharmacologists, representing more than 20 countries and all continents, were welcomed by Dr Stuart MacLeod (Department of Paediatrics, University of British Columbia, and Child & Family Research Institute, Vancouver, BC, Canada) representing the International Alliance for Better Medicines for Children (IABMC). Plenary sessions, lectures, round table discussions and workshops were given/led by an international contingent of experts. The content reflected the interdisciplinary nature of paediatric therapeutics, covering, in addition to clinical pharmacy and pharmacology, drug policy, drug safety, pharmacogenomics, drug regulation, international health, pharmacy education and pharmaceutical formulation science. The themes of the symposium were outreach, translational research and clinical practice. Within this framework, presenters and attendees examined how paediatric pharmacy and pharmacology, through international collaboration, can contribute to optimal drug therapy for the world’s children. The need for multidisciplinary networks through enhanced communication and collaboration was evident throughout the meeting; practitioners, educators and researchers from industry, government and pharmacy organizations emphasised this. Representatives included Dr Agnes Saint Raymond (European Medicines Agency [EMEA]), Ms Sara Arenas (European Society of Clinical Pharmacy [ESCP]),Dr David Hoff (American College of Clinical Pharmacy’s [ACCP] Practice and Research Network [PRN]), Dr John van den Anker (European Society for Developmental Perinatal & Paediatric Pharmacology [ESDPPP]), Dr Michael Christensen (Pediatric Pharmacy AdvocacyGroup [PPAG]),DrGeorge Giacoia (National Institutes of Health [NIH]), Dr Suzanne Hill (WHO), Dr Sharon Conroy (Neonatal and Paediatric Pharmacists Group [NPPG]) and Dr Klaus Rose (Roche). They identified specific areas to target, including (i) enhancing undergraduate and graduate training in paediatric pharmacy; (ii) developing a system for data integration and information sharing across countries; (iii) focusing on collaborative research and capacity building of researchers/ clinicians; (iv) increasing the quality of paediatric drug clinical trials in all age groups (including neonates and pregnant women) and increasing the number of multicentre trials to maximize the use of a limited pool of patients; (v) advocacy of paediatric medication issues through government and nongovernment non-profit entities and the pharmaceutical industry; (vi) focusing on formulations, unlicensed use of medications, reference sources and prescription monitoring; (vii) identifying the players (product, supply, research, use, policy, pharmacoepidemiology) and including representatives inmultidisciplinary teams; and (viii) offering knowledge to developing countries and encouraging trained paediatric clinicians to reach out to the remote and underserved. There are both many challenges and opportunities. There is a lot of enthusiasm within the sector but the workload is huge, and paediatric pharmacists and pharmacologists are underrepresented. We need to learn from past mistakes, maximize

Neonatal and Paediatric Pharmacists Group, 12<SUP>th</SUP> Annual Conference

Neonatal and Paediatric Pharmacists Group, 12<SUP>th</SUP> Annual Conference

Littluns and biguns

It is hard to establish how to give children adequate drug therapy. Defining drug pharmacokinetics and pharmacodynamics in children is a difficult affair; determining suitable ageand weight-related doses lacks a sound scientific basis; and randomized controlled trials in children are relatively few. Thus, licensed indications and recommended dosage schedules often do not encompass the young. Off-label use is therefore common, and one suspects that the balance of benefit to harm in drug therapy in children must be generally less favourable than it is in adults, although the evidence that that is so is still limited. Part of the problem has been that paediatric clinical pharmacology is a relatively neglected subspecialty. It is encouraging therefore that there are now three paediatric clinical pharmacologists in the UK and three others in training. It would be interesting to know what the position is in other countries. In this issue of the Journal Choonara et al. (pp. 217–18) announce the formal training programme for paediatric clinical pharmacologists that has been developed under the auspices of the Royal College of Paediatrics and Child Health. The programme is encouragingly eclectic, and it is good to see that it includes population pharmacokinetics, which, although an arcane and difficult subject, is important in studying children, in whom blood samples are often sparse. The requirement that each trainee will be responsible for a paediatric trial is also welcome. How many trainees the subspecialty will attract remains to be seen; training involves triple accreditation (in general medicine, paediatrics, and clinical pharmacology) and the going must be tough. But the challenge will be a stimulating one and the rewards worth striving for. In a parallel initiative, the British National Formulary is currently working on a children’s BNF, in collaboration with the Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists Group. And granting extended exclusivity rights to pharmaceutical companies during drug development may encourage more premarketing studies in children.

Neonatal and Paediatric Pharmacists Group, 9th Annual Conference

Neonatal and Paediatric Pharmacists Group, 9th Annual Conference

Dose estimation for children.

There is a wide perception that the paediatric population has been badly served by pharmaceutical companies, drug regulators and governmental funding bodies, in that too little resource has been committed to developing effective and safe medicines for children, and in particular defining the right dose(s) for appropriate paediatric populations (see for example reference [1]). Paediatricians, clinical pharmacologists and clinical pharmacists have for many years struggled to make the best use of information available to them, as evidenced by local paediatric formularies, and, more recently, the formulary published by the Medicines Committee of the Royal College of Paediatric and Child Health and the Neonatal and Paediatric Pharmacists Group [2]. This review explores three areas of this problem: Is this perception true? Does it matter? What is the evidence of harm? If it does matter, what can be done about it? Is it true? With some notable exceptions, the vast majority of drugs have been developed for use in adult populations. The reasons for this have been well explored already [1, 3–7] and include ethical objections to conducting clinical trials in children, the resource (expense and time) that is required to discover and develop new drugs where the use in paediatric populations represents a poor return on investment, and the uncertainty of types of clinical trials in children that will satisfy both regulatory authorities and prescribers as to the efficacy, safety and quality of new potential medicines. It is worth considering this latter point in some detail. Defining the optimal dose, the dose range for a given patient population, and the dose adjustments required as a result of physiological, pathological or iatrogenic interventions (such as drug interactions) remains one of the most challenging tasks in drug development and clinical care. It is not uncommon that the dose or dose range for a given drug established at the time of marketing authorization is significantly modified with experience in clinical practice. Adjustments are most frequently downwards (e.g. treatment of essential hypertension) [8]. Often these dose changes for adult populations take many years to establish. Further, it is only with the passage of time and clinical experience that differences in dose–response in populations emerge; for example, the greater response in young white hypertensives to β-blockers, compared with older and black patients. The realization of defining ‘the right drug for the right patient (at the right dose)’, according to genotypic and phenotypic profile for the vast majority of drugs lies well into the future. Our ignorance of the inherent heterogeneity of an apparently homogeneous group of adult patients has served us rather well for many commonly used drugs, especially for those drugs with wide therapeutic ratios and whose pharmacokinetic variables are well understood. One major stumbling block for dose estimation in children is the very definition of the word ‘children’. Most guidelines now use the age bands recommended in Licensing Medicines for Children 1996, a joint report of the British Paediatric Association and the Association of the British Pharmaceutical Industry [9]; namely newborn (birth to 1 month), 1 month to 2 years, 2–12 years and 12–18 years. The drug monograph on Medicines for Children, prepared by the Medicines Committee of the Royal College of Paediatric and Child Health and the Neonatal and Paediatric Pharmacists Group [2], expresses dosing using these age bands. The monograph also highlights another problem: what units should be used. In Medicines for Children specific doses are generally stated on a per weight or by an age/weight basis. Occasionally, doses are stated on a specific ‘dose/surface area basis’[2, 10]. It is presumed that these dosages are based on the information in the Summary of Product Characteristics (SPC) provided by the pharmaceutical companies, and supplemented by information from ‘off-label’ use in clinical trials and in clinical practice.

Do We Need a Neonatal and Paediatric Pharmacists Group in Australia?

The Australian Journal of Hospital PharmacyVolume 28, Issue 1 p. 68-68 Letter to the EditorFree Access Do We Need a Neonatal and Paediatric Pharmacists Group in Australia? Sean Turner, Corresponding Author Sean Turner Senior Clinical Pharmacist Princess Margaret Hospital for Children GPO Box D184 Perth WA 6001E-mail: Sean.Turner@health.wa.gov.auSearch for more papers by this author Sean Turner, Corresponding Author Sean Turner Senior Clinical Pharmacist Princess Margaret Hospital for Children GPO Box D184 Perth WA 6001E-mail: Sean.Turner@health.wa.gov.auSearch for more papers by this author First published: 01 February 1998 https://doi.org/10.1002/jppr199828168AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume28, Issue1February 1998Pages 68-68 RelatedInformation