Neonatal and Paediatric Pharmacist's Group (NPPG)

Newsletter No. 8

June 1998

Editor:

Peter Mulholland
Pharmacy Department Southern General Hospital
1345 Govan Road
GLASGOW G51 4TF
Tel: 0141 201 1382
Fax: 0141 201 2996
email: pmulholland@sghpharmacy.demon.co.uk

NPPG 4^th ANNUAL CONFERENCE Dublin 2^nd - 4^th October 1998

This years conference will be held in the Malahide Hotel, Dublin. The draft programme includes:

Poster session on "Novel developments In Neonatal And Pharmaceutical Care"
Paediatrics In Ireland
Clinical Pearls in Neonates and Paediatrics
(You will be receiving a flier for contributions to this section)
Updates on Dial, Paediatric Formulary and current research

Workshops including Neonatal and paediatric TPN, Managing new drugs in paediatrics, HIV in neonates and Paediatrics, Neonatal withdrawal, Use of patients own medicines, paediatric renal disease, pain relief, palliative care and case studies.

Costs are:

• Members: £220 (double room); £250 (single room)
• Non members: £240 (double room); £270 (single room).
• There will be a late payment surcharge of £30 for registration after 1^st September.

Further details from:

Siobhan Moriarty MPSI
Chief Pharmacist
Our Lady's Hospital For Sick Children
Crumlin DUBLIN D12

Phone: 00-353-1-4551920
Fax: 00-353-1-4558004

OTHER UPCOMING CONFERENCES

There is to be a Paediatric Clinical Pharmacy Conference in Barcelona, Spain in November 1998.
Details can be obtained from:

Pharmacy Service
Hospital Materno-infantil Vall d'Hebron
Vall d'Hebron 119-129
08035-Barcelona
SPAIN

Tel: 34-93-489 3117
Fax: 34-93-489 3115

An International Symposium on headache in Childhood and Adolescence will be held in Budapest on July 14 1998.
Topics will include pain in the paediatric patient and appropriate migraine therapy for children.
Full details can be found on http://www.pro-patiente.hu/md/soc/congrex/0010/88 or by post from:
E+L Ltd,
H-1052 Budapest,
Semmelweis u.10,
Hungary

The 6^th International Congress on Amino Acids will be held in Bonn from 3^rd - 7^th August 1999. Among topics to be covered are Molecular medicine, Nutrition, Pharmaceutics, Taurine, Inborn Errors and Pharmaceutical Chemistry. Papers are being called for. The deadline for submission is January 31^st 1999.
Further details can be obtained from:

Dr O Labudova
Rheinische Friedrich-Wilhelms-Universit
Experimetnell Radoilogie und Strahlenbiologie
Sigmund-Freud-Strasse 25
D-53105 Bonn, Germany

Email: hrink@mailer.meb.uni-bonn.de

COMMITTEE DETAILS

Following requests, below are the fax numbers and E-mail addresses of committee members.

NEWS FROM THE REGIONS & SUB-GROUPS

London

London members of the NPPG met recently to establish a rolling programme of meetings to discuss topics of interest and to share information. Meetings will take place every two months with the venue rotating. Upcoming meetings are:

• 27^th July - Meningitis
  Venue: St Mary's (Contact: Susan Lambers 0171 886 6046)
• 28^th Sept - Liver disease
  Venue: King's College (Contact: Penny North-Lewis 0171 346 3347)
• 30^th Nov - Gastroenterology
  Venue: Chelsea & Westminster (Contact: Simon Keady 0181 608 6348)
  

Summaries of the meetings will appear in future newsletters.

POP Group

POP Group and the Paediatric Chief Pharmacists Group 'Guidance on the Management of Intrathecal Therapy in Paediatric Oncology' has been updated and the guidance has been sent to Professor Sir Kenneth Calman (Chief Medical Officer, Department of Health) requesting that the document be reviewed in conjunction with advice from other interested authorities and that guidance be issued to all health care professionals.

(Update: This has since been sent to the Medicines Committee of the Royal College of Paediatrics and Child Health and Bryan Hartley (Chief Pharmacist DoH) and these have noted receipt. The Paediatric Trust Chief Pharmacists have agreed that the document is of sufficient importance that they have agreed to issue it to all NPPG members and it is included with this newsletter.)

In addition the group recommends that an administration system be developed so that lumbar puncture needles used for intrathecal drug administration cannot to standard Luer injection syringes. This would then require that intrathecal drugs are prepared in the pharmacy in a syringe designed for intrathecal use.

The POP group have introduced two annual awards. They are open to Pharmacist members of POP, NPPG or BOPA.

The first  is a poster award that is for practice research or service development carried out in the field of paediatric oncology and is valued at £250. The award applies to work to be completed within 1 year of the award and must be presented at an international or national oncology, clinical or paediatric conference during the year of the award.

The second award is a research award worth £750 to support original research into paediatric oncology in one of the following areas:

• Clinical research & development
• Education & training
• Pharmaceutical research & development
• Homecare
• Intravenous therapy
• Health & safety
  

Applications may be considered on behalf of groups. The successful applicant(s) should be prepared to present the research at an international or national oncology, clinical or paediatric conference.

Further details are available from Caroline Osborne at Alder Hey Children's Hospital.

SNAPP Group

Meeting held May 1998.

SCPPE meetings: Following on the previous successful Scottish tour where group members were involved in the Paediatric element of the post qualification training courses a further series of meetings is being arranged. The first meeting will be in Kirkaldy on 3^rd November. Topics to be covered are: seamless care and unlicensed medicines, iron and fluoride supplementation and drugs in pregnancy and breast feeding.

NOTES ON THE JOINT MEDICINE COMMITTEE OF 3 JUNE 1998.

Attended, and contributed, by Tony Nunn

A proposal for a national centre for the study of medicines in children is being developed. It is envisaged that this would be similar to the American model of Paediatric Pharmacology Research units. A parliamentary written reply from the Minister of Health (Mr Boateng) to a question about unlicensed and off-label medicines for children said that the government 'shall be guided by the Royal College of Paediatrics' on these issues.

A policy statement on the use of 'licensed medicines for unlicensed applications, and the use of unlicensed medicines' is being drawn up by the Medicines Committee to 'assist and guide those who have responsibility to prescribe, dispense, or administer medicines for children'. It is intended that the policy should be adopted by RCPCH and NPPG and would assist in those confrontational situations where, for example, a Trust tries to 'ban' or restrict the use of such medicines.

A computer-generated patient information leaflet that gave misleading information on the adverse effects of liquid paraffin (!) was considered. It raised the issue of quality standards for such leaflets and the MCA will be asked to comment.

The issue of the unlicensed status of most radiopharmaceuticals for children was considered and the policy statement, when available, will be sent to the Intercollegiate Standing Committee on Nuclear Medicine prior to further discussion.

Comment was passed on an MCA consultation letter MLX 240 which seeks to give GSL status to rehydration powders and various preparations of topical lignocaine and benzocaine for the treatment of pruritis and for pain relief. The committee have expressed their concern that no separate consideration was given to paediatric requirements and that the local anaesthetics should be reconsidered in terms of patient safety before extending the GSL status to paediatric applications.

The committee had previously endorsed recommendations on reducing errors during intrathecal drug administration sent by the POP group and the Paediatric Hospitals Chief Pharmacists Group to the Department of Health. As a matter of report it was noted that Tony Nunn and Caroline Osborne have been invited to attend a discussion with Dr Keith Ridge, DoH.

The draft of Medicines for Children is out for expert review by the various speciality sections of RCPCH and pharmacy generalists and specialists. We hope that the publication will be available at the end of the year.

NPPG is keen to see that items from the membership are discussed by the Medicines Committee which, you will remember, is a multidisciplinary, JOINT committee of NPPG and the Royal College of Paediatrics with observers from DoH and CSM. The next meetings are 29 July and 29 September. Contact Tony Nunn (Alder Hey, Liverpool), Rowena McCartney (University Hospital, Cardiff) or Leonie Duke (Guy's, London) if you have comments or wish items to be considered.

INFORMATION ON THE INTERNET

  If anyone finds any other useful sites let me know at the address above and I will include them in the next issue.

BMJ - THE HEALTH OF CHILDREN

The BMJ recently (23 May 1998 No 7144) devoted virtually an entire issue to the subject of child health covering a wide variety of topics. It is worthwhile reading for any NPPG member.

Email ADDRESSES

RESPONSE TO QUERIES

Sharon Conroy has supplied the following responses to queries in Newsletter 7.

Naomi Raeburn's query re arachis oil.
The Derbyshire Children's Hospital changed about a year ago to the use of olive oil for topical use, and for mixing with paraldehyde for rectal administration. We do still use arachis oil enemas occasionally.

Naomi's query re dispensing of liquid medicines and child resistant caps.
In Derby a child-resistant cap is always used, if there is not one available to fit a manufacturer's bottle then even original pack volumes will be packed down into standard medicine bottles for which a child-resistant cap is available. This applies to adults and children's prescriptions, the only exception being when 'ordinary' caps are specifically requested by the prescriber or patient, appropriate counselling re storage of medicines away from children should be given in this situation.

Sherry Wright's query re Intralipid in premature babies.
In Derby we have one regime for all gestations/birth weight babies in the NICU. This involves starting at 5ml/kg body weight on day 1, 10ml/kg on day 2, 15ml/kg on day 3, 20ml/kg on day 4. The total TPN volume of 150ml/kg/day is made up with the amino acid/glucose/electrolyte bag. Fat is not given in babies on or above the line for phototherapy.

LECTURER IN PAEDIATRIC CLINICAL PHARMACY PRACTICE
report from Sharon Conroy

I started this post on 2nd February of this year. Here is a brief summary of my experiences so far.

Most of my time is currently spent on projects looking at the nature and extent of unlicensed and off label use of medicines in children. We all recognise this as being a 'big' problem in children - but how big is it really, what problems does it cause the professionals involved in caring for children and what can we do about it? I am exploring these issues in the following areas so far:

• Neonatal Intensive Care Unit -retrospective study completed, to be presented as an oral communication at the 6th Congress of the European Society for Developmental Pharmacology in Corsica in June ( A report on this congress will appear in the next newsletter ). Prospective study underway.
  
• Paediatric Intensive Care Unit and general paediatric wards - similar projects just started with data being collected by paediatric pharmacists in the Derbyshire Children's Hospital for analysis by myself.
  
• Prescribing in the community - analysis of prescribing data provided by local GP underway.
  

Similar projects in other paediatric centres across Europe hopefully will start soon, data to be analysed here to compare the situation in the UK with that across Europe.

Another project to commence soon is to look at the use of intranasal midazolam for the treatment of convulsions instead of using rectal diazepam. This project will involve paediatricians, nursing staff and myself.

At the same time I am still providing a daily clinical pharmacy service to the neonatal intensive care unit and attempting to further develop protocols and drug information resources on this unit.

Projects for the future are likely to include;

• looking at sedation for procedures in children
• caffeine vs. cisapride in neonates suffering apnoeas
• treatment/prevention of pain in the neonate.

If any NPPG members have any ideas for burning issues in paediatric drug therapy which need to be investigated which we may have the time/resources to help with please do not hesitate to contact me.
Email : sharon.conroy@nottingham.ac.uk

CONFERENCE REPORTS

ESCP 1^st European Conference on Mother and Child Health,Budapest,
22-24 April 1998

The official report from this conference will be appearing in either the Pharmaceutical Journal or Hospital Pharmacist.. NPPG was reasonably represented with 3 members contributing to the conference either by lectures, running workshops or poster communications. There was not a huge UK attendance, possibly due to the lack of publicity. However those attending made several useful European contacts to facilitate information exchange throughout the continent. What appears below is the views of some of the other attendees at the conference to give an alternative view.

Antonio Addis, CRIF DI Center, Institute Mario Negri, Milano

The principal topic of the conference was per se interesting for the following reasons:

• ethical and methodological issues make this field an orphan of research;
• scarce information on risk and safety of drug use, make it difficult to identify rational evidence based pharmacotherapy for mothers and children

In this context, the role of the pharmacist is still not explicit and the potential possibilities calls for a better involvement in this field.

The conference has been important to point out how pharmacists may be involved to inform the public and health operators (e.g., Drug information, problem oriented, pamphlet, campaigns, etc.). Furthermore, new methodological approaches to investigate risk and safety associated to drug use in mothers and children (e.g., specialised TDM programmes, Collaborative Multicenter studies, etc) were presented.

A large number of drugs, usually prescribed to children, are actually off-label, and this creates additional difficulties regarding dosages and indications where pharmacists may be of great help.

In conclusion, a network of professionals in the clinical pharmacy area, interested in this field will make it easier to share experiences and information and to create a multicenter observational observatory on drug use in this "grey area" of pharmacotherapy

Hedvig Nordeng, Department of Pharmacotherapeutics, University of Oslo, Norway.

For a young researcher in clinical pharmacy working with pharmacotherapy during pregnancy and lactation, the 1st European Conference on Mother and Child Health made an unforgettable impression.

During lectures and workshops it became clear that the same problems and needs exists throughout Europe. Great concern was contributed to providing and giving information about drugs during pregnancy and breastfeeding. The lack of reliable documentation on drug safety during these periods was emphasised. It is known that pregnant women have a great concern about using medicines. Fear of harming the unborn child is high, though only very few drugs are proven teratogens. Working towards more standardised information may improve compliance during pregnancy and breast feeding. The importance of collaborating within Europe in this work was recognised. An informal group of European pharmacists will be established in the near future to work with pharmacotherapeutics and pregnancy/ lactation.

The conference stressed the importance of therapeutics in neonatal and paediatric patients. Lack of licensed drugs in paediatric patients was of concern throughout Europe. It is a great paradox that least information exists in those who are the most vulnerable. More pharmacists should be working as part of multidisciplinary teams caring for paediatric patients as the results from this kind of work is very successful.

The congress gave the opportunity to discuss difficult questions, share experiences and direct awareness to necessary areas of work for the future.

E.S.C.P. Paediatric SIG Meeting, Tours, France
October 1997

The following has been reproduced by kind permission of the ESCP Paediatric SIG co-ordinator (Jacqueline Grassin) from their recent newsletter.

Prescribers, pharmacists and care givers are confronted daily with the problem of drugs without paediatric indications within marketing authorisations (M.A.) and the lack of written information on paediatric drugs. In this context Paediatric SIG members decided to investigate the following three topics:

• drug registration for paediatric use
• pain management in paediatrics
• pharmaceutical care in the paediatric intensive care unit.

Drug registration for paediatric use

In Tours, Jacqueline Grassin, SIG co-ordinator, presented the results of a questionnaire sent to all SIG members (25 members representing 14 countries). This questionnaire included a list of drugs currently used in the paediatric hospital in Tours and marketed in France without any labelling for paediatric indication. These drugs belong to three therapeutic classes, blood and immunosuppresive agents. It was asked whether drug products have paediatric indications in other European countries. Thirteen members answered the questionnaire, showing the large disparity in the legislation of paediatric drugs.

Blood and cardiovascular agents

Out of 42 drug trade names, Belgium and Hungary had respectively 33% and 24% paediatric indication, but Norway only 5%. For example, Propranolol is marketed with a paediatric indication in 4 countries, like lignocaine, but captopril does not have any paediatric M.A. at all.

Gastrointestinal agents

In Turkey, as in France, no products have a paediatric M.A. Spain and Portugal have a paediatric M.A. for 3 out of the 22 drug trade names included in the questionnaire. Belgium seems favoured with 32% of drugs with paediatric indications. Granisetron is marketed for paediatrics in Belgium, Hungary, Norway and Spain. Currently used products like ursodeoxycholic acid have a paediatric M.A. in Portugal.

Antineoplastic agents

For each of the antineoplastic agents (34 drug trade names) there is at in least one country a paediatric M.A. Spain is the country with most paediatric M.A. (97%), whereas in Turkey the rate does not exceed 35%

Action proposals

If a drug is granted with a paediatric M.A. in one European country, why not in all European countries?
SIG members have selected specific drugs, in several European countries, according to the following criteria:

• currently used products
• products with a high risk use
• products with a paediatric M.A.

They decided to harmonise paediatric M.A. in Europe by contacting the pharmaceutical industry and a European agency

Distinguish Between Caffeine and Caffeine Citrate Dosage

Contributed by: Sherry Wright, Pharmacy Department, Edinburgh Royal Infirmary

Caffeine is commonly prescribed as the caffeine citrate salt. Dosage if prescribed as caffeine is 50% of that when prescribed as caffeine citrate. It is important to specify exactly what is needed to avoid confusion and inappropriate doses. Current dosage guidelines for Caffeine Citrate in the neonate are 20mg/kg/dose as a loading dose (by I/V or oral route) followed by 5mg/kg/day once daily (I/V or oral) as a maintenance dose. recent population pharmacokinetics ¹ of caffeine have suggested that routine monitoring of serum caffeine concentration is not necessary. We advise adjustment of dose according to body weight after the first month of treatment unless clinically indicated otherwise.

Reference
1 Thomson AH, Kerr S, Wright S, Population Pharmacokinetics of Caffeine in neonates and young infants, Therap Drug Monit, 1996, 18, 245 - 253

European Collaboration on Drugs in Pregnancy and Breast feeding

A workshop on Drug Information in Pregnancy and Breast Feeding at the recent conference on Mother and Child Health in Budapest identified the need for more collaboration across Europe between pharmacists involved in this field. Delegates attending the workshop have proposed the formation of an informal group of pharmacists who are interested in this field and are willing to collaborate and share information. Examples of areas of interest would include:

• Information provision for prophylactic drug use in pregnancy e.g. folic acid
• Optimal drug (or non drug use) during pregnancy/breast feeding e.g. epileptic therapy
• Treatment for acute illness during pregnancy e.g. nausea and vomiting
• Studying women's perceptions of dangers of drug use during pregnancy in Europe
  

We believe non-compliance during pregnancy is partly due to fear of harming the unborn child. This anxiety can cause more harm than the drugs themselves as pointed out by Professor Cziezel in his lecture. When these women choose to not take their medication it is because they believe they are protecting the child. In many cases (infections) they are doing the opposite.
The intention is to compile a database of interested pharmacists who could then circulate information or requests among the group. It could also open up the possibility of cross Europe collaboration on research projects.
Anyone interested in joining the group should contact Antonio Addis at Addis@irfmn.mnegri.it

Vitamin K in New Born Babies

Additional Vitamin K is widely used for prevention of vitamin K deficiency bleeding in new-born babies. The Department of Health have issued updated guidance on this subject (PL/CMO/98/3 in England and Wales, SODH/CMO (98) 11 in Scotland).
The complete document (in English) can be found on the government web site at http://www.open.gov.uk/doh/cmo/cmo98_3.htm

PAEDIATRIC and NEONATAL INFORMATION SHARING
REQUESTS

Wendy Humphries (Holten General Hospital, Oxford)
is looking for copies of protocols used for sedation during minor procedures.

Alenka Pecar, (Apotheke Klinikum Innenstadt, München)
asks: Indomethacin is not licensed in Germany for PDA closure. We have used an indomethacin preparation from Italy and have switched to Indocid PDA from the UK (MSD). How do you handle the stability information ? Do you use Indocid for 24 hours or do you discard them after use ? I suppose you in the UK mostly prepare patient-individual syringes in the pharmacy; unfortunately in our hospital the nurse on the ward prepares the syringe. (Replies to Peter Mulholland  please)

DID YOU SEE? APR/MAY 98

Compiled by Andy Fox (Portsmouth Hospitals). It contains a list of paediatric references that members may have overlooked. The idea behind it is that readers can scan the list and may see something of interest that they may have missed or an article that is the answer to a current problem.

ABC of Palliative Care - Special problems of children.
Goldman A. BMJ. 1998; 316: 49-52.

Neonatal vitamin K prophylaxis: the Gordian knot still awaits untying.
BMJ 1998; 316: 161-162.
This good editorial covers the history relating to the vitamin K problem and critically analyses four studies which appear in the same issue of the BMJ (17/01/98). Some questions are answered but just as many if not more are remain unanswered. This issue of the BMJ is essential reading for those involved with this tricky subject.

Gentamicin Monitoring in Paediatric Patients.
Robinson JD. Ann Pharmacother 1997; 31: 1539-40.
A short editorial discussing the monitoring of gentamicin levels in light of an article in the same issue (below).

Routine monitoring of gentamicin serum concentrations in paediatric patients with normal renal function is unnecessary.
Logsdon B, Phelps S. Ann Pharmacother 1997; 31: 1514-8.
A study of 150 patients aged between 3 months- 15 years with normal renal function prescribed gentamicin at a mean dose of 2.51mg/kg 8 hourly. Peak concentrations were > 4mg/l in 96% of samples and < 2mg/l in 100%. The authors concluded that monitoring need not be performed routinely in patients with normal renal function.

Are children given insufficient pain relieving medication postoperatively.
Hamers J. et al J of Adv Nursing. 1998; 27: 37-44.
A literature review.

Pharmacokinetics and phamacodynamics of recombinant human growth hormone by subcutaneous jet- or needle-injection in patients with GH deficiency.
Houdijk EC et al Acta Paediatr 1997; 86: 1301-7.

Recombinant erythropoetin for the anaemia of prematurity: Still a promise, not a panacea.
Strauss RJ. J of Pediatr 1997; 131: 653 - 655.
An editorial covering another article in the same issue (below).

The effect of erythropoetin on the transfusion requirements of preterm infants weighing 750g or less: a randomised, double-blind, placebo-controlled study.
Ohls RK. et al. J Pediatr 1997; 131: 661-5.

The Use of Omeprazole in the Pediatric Population.
Walters JK, Zimmermann AE et al. Ann Pharmacother 1998; 32: 478-481.

Keeping the stork at bay until the time is right.
Bonn D. Lancet 1998; 351: 576.
A short feature article on prevention of neonatal birth.

Unlicensed and off label drug use in paediatric wards:
prospective study. Turner S et al. BMJ 1998; 316: 343-5.

Host defense-A role for the amino acid Taurine.
J Parent Ent Nutrit 1998; 22: 42-48.

NPPG COMMITTEE MEETING

20^th MAY 1998

Tony Nunn is preparing a position paper on representation on the Royal College of Paediatrics and Child Health (RCPCH) Medicine Committee by NPPG members. This is a joint committee between the two organisations.

Two pharmaceutical companies have so far expressed in an interest in corporate membership.

Conference poster session on "Novel developments In Neonatal And Pharmaceutical Care" - Astra have funded an award of up to £1,000 to enable the winning poster to be presented at an international conference in the following 12 months

Return to Pharmacy On-Line Contents