International initiatives on extemporaneous dispensing

Transcription

1 Partners meeting WHO, Geneva November 2011 International initiatives on extemporaneous dispensing Tony Nunn and Mark Turner UK Medicines for Children Research Network University of Liverpool Industry Professor Liverpool John Moores University Anita Aindow Alder Hey Children s Hospital, Liverpool David Woods University of Otago, Dunedin, New Zealand

2 Definitions "the manipulation by pharmacists of various drug and chemical ingredients using traditional compounding techniques to produce suitable medicines when no commercial form is available * may also be prepared from authorized dosage forms and commercial or locally produced suspending agents compounding preferred term *Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European Hospitals. Acta Paediatr. 2003; (294):

3 Need Western countries Practitioners off label use of medicines Industry clinical trials small markets/difficult formulations Regulators quality bioavailability Resource poor countries Access liquid medicines not listed/purchased Cost Liquid medicines 20x more expensive than solid dosage forms

4 EMLc Lists some ageappropriate formulations but not available in all countries 3 rd edition March 2011

5 WHO Model Formulary for Children Lists some age-appropriate formulations but not available in all countries

6 Availability of essential medicines for children Robertson J et al (2009). What essential medicines for children are on the shelf? Bull World Health Org; 87(3):231-7

7 Information about compounding Commonwealth Pharmacists Association (Farwell, J) Survey results (initial) 11 Anglophone African respondents 60 preparations 33/60 (55%) available as authorised age appropriate formulations in UK Commonest Oral furosemide; ciprofloxacin; digoxin; paracetamol Oral quinine; isoniazid Woods, D Information requests (paediatric formulations database) 332/475 (70%) about compounding of preparations available in other markets Commonest Quinine; rifampicin; prednisone

8 Availability of ingredients for compounding Active ingredients Sources; cost; quality Suspending agents Availability; cost Excipients Availability; cost; quality e.g. Tamiflu authorized compounded liquid requires North American label Cherry Syrup (Humco ) Ora Sweet SF (Paddock Laboratories) EU SmPC Sodium benzoate 0.1%

9 Medication error potential Choonara I. WHO wants safer medicines for children. Arch Dis Child 2008;93: e.g. diethylene glycol in place of propylene glycol wrong strength chloroform water

10 WHO/UNICEF Copenhagen 2010 Review commissioned Existing guidance/advisory documents how medicines should be administered to children General instructions on compounded preparations manipulation of adult dosage forms Guideline to be prepared Extemporaneous dispensing and administration of medicines to children

11 Progress Early draft guideline considered EMLc committee meeting, Ghana, March 2011 Final drafts WHO informal consultation on paediatrics and generics guidelines development, Geneva, May 2011 (amended from comments) WHO Expert Committee on the Specification of Pharmaceuticals, Geneva, October 2011

12 WHO view Concerned about risks of inappropriate compounded preparations diverting efforts aimed at the development of age appropriate dosage forms for children potentially conflicting signals arising from a WHO publication that might appear to endorse wider use of manipulation of adult dosage forms for children Agreed finalise for publication as a time limited guidance that addresses the current need for advice amend title because of lack of clarity around extemporaneous Provision by health care professionals of patient specific preparations for children that are not available as authorized products points to consider rather than guidelines

13 WHO view WHO endorsement of extemporaneous use should not be seen as indicating a lack of need for commercially available paediatric dosage forms Recommendations removed

14 WHO view WHO Expert Committee on the Specification of Pharmaceuticals, Geneva, October 2011 unedited minutes The Expert Committee expressed appreciation of the document as a source of general guidance. The Committee advised that the document could be further developed jointly by WHO and FIP as practice guidance for compounding. No mention of the recommendations

15 Main themes of guidance Ensure commercial age appropriate dosage forms available whenever possible Compounding as a last resort Prescribers aware of the dosage forms available locally Rationalised prescribing education Dose rounding information in Model Formulary Therapeutic substitution guidance required Manipulation of dosage forms Investigation and information Assurances and information from manufacturers

16 Main themes of guidance Compounding as a last resort Use adult dosage forms + suspending agent Generic suspending base to be developed Stability studies with common drugs Dry powder version for reconstitution Information on validated, simple formulations List of safe excipients Formulations with minimum of excipients Establish minimum standards Education and information Drug administration and compounding Link paediatric centres and share information

17 Industry can help Affordable Age appropriate dosage forms WHO priority list WHO EMLc Suspending vehicles Validate Compounding from adult dosage form With ingredients readily available Manipulation of adult dosage forms Including addition to food, milk and liquids Make information available

18 Recommendations Abridged version vailable in hard copy Provide information in WHO model formulary

19 Western countries Therapeutic orphans Harry Shirkey (1963) 1 no authorised medicine little information no age appropriate formulation Conclusion Resource poor countries May have no medicine at all Action required Recommendations should be fully evaluated 1 Shirkey H. Editorial comment: Therapeutic Orphans. J Pediatr 1968: 72:

20 Resources Draft points to consider document afety/quality_assurance/provisionhealthcare Professionals_QAS11 399Rev1_ pdf Draft literature review afety/quality_assurance/review findings PaediatricMedicnesAdmin_QAS11 400Rev1_ pdf