1. Regional Agreements on Dermatological Extemporaneous Preparations Dermatologische Magistralrezeptur: Erfahrungen und Empfehlungen aus Holland FTTO RADA Leiden e.o. Annemieke Floor-Schreudering

2. BAK-Workshop 16-11-20072 Content Motivation for starting the project Introduction Problems Aims Methods Assessment ‘Magistralrezeptur’ Regional standardized preparations Products Evaluation

3. BAK-Workshop 16-11-20073 Motivation for starting April 2001: Regional course on Psoriasis with consultant dermatologist July 2001: Dermatologist meeting in Leiden academic medical centre July 2001: Inventory of interests among health care members December 2001: Start national projectgroup: multidisciplinary agreements dermatological pharmacy compounded medicines April 2002: Start regional project

4. BAK-Workshop 16-11-20074 Introduction Dermatological preparation is 44-57% of the ‘Magistralrezeptur’. 50% is a non-standardized dermatological prescription. Prescriber is 20% dermatologist and 80% general practitioner. Both prescriber and compounder are responsible for rational and technical high quality pharmacy compounded medicines. [1] Foundation for Pharmaceutical Statistics (SFK), The Hague 2001 [2] Deutschen Arzneiprüfungsinstituts e.V. 2006 [3] Buurma H, et al. PWS 2006; 25 (6):280-287

5. BAK-Workshop 16-11-20075 Problems Diversity in prescribing behaviour Difficult communication –Dispensing irrational and low quality preparations –Pharmacists change prescriptions without consulting the prescribing doctor –Miscellaneous or no protocols used –Inconsistent patient information –Patient has to wait for the preparation

6. BAK-Workshop 16-11-20076 Aims To improve efficient pharmaceutical care to individual patients using dermatological preparations To increase quality and effectiveness of dermatological preparations –Promote rational prescribing behaviour –Enhance standardization (80% at dispensing) –Implementation of a regional formulary –Promote the use of protocols/ instructions –Improve the communication and exchange of information between regional health care providers

7. BAK-Workshop 16-11-20077 Methods Create support: “soundboard group” Appoint working groups Base line measurement: Inventory of ‘Magistralrezeptur’ Assessment of the rationality of dermatological pharmacy compounded medicines Formulary and agreements non-formulary preparations Implementation among health care members Effect-measurement

8. BAK-Workshop 16-11-20078 Assessment inventory of “Magistralreceptur Reaching consensus is difficult because of Differences in knowledge level care members Different therapy opinions among dermatologists related to education region Prescribing is tradition and empiry based Different opinions on user friendly Reimbursement difficulties

9. BAK-Workshop 16-11-20079 Do you believe the efficacy of the preparations prescribed or dispensed by yourself is convincing?

10. BAK-Workshop 16-11-200710 Concentration of corticosteroids 0.025%, 0.1% and 0.5% triamcinolone acetonide in a topical preparation have the same biologic activity. 1.0% and 2.5% hydrocortisone acetate have equal therapeutic effectiveness

11. BAK-Workshop 16-11-200711 Do you prescribe or dispense brand name products with an extra component?

12. BAK-Workshop 16-11-200712

13. BAK-Workshop 16-11-200713 Adds to brand name products Medical information manager: “There are only few data known on clinical efficacy and safety of combination preparations (components added to brand products). Therefore the Laboratory of Dutch Pharmacists (LNA) advises against.” ”The test results only prove physical stability of the combination preparation for 35 days. On efficacy of the preparation nothing can be said.”

14. BAK-Workshop 16-11-200714 Decisiontree dermatological preparations Approved by Klankbordgroep RADA project 13 april 2003 Is an authorised product available? Is a national standardized (FNA/LNA) product available? Choose this product Is a non-standardized product following the assessment scriteria available? Contact between pharmacist and prescribing doctor about quality and reason of prescription and possible alternatives. no yes no Choose this national standardized product Is a regional standardized product available? yes Choose this regional standardized product yes Choose this product no

15. BAK-Workshop 16-11-200715 Assessment criteria non-standardized products Approved by Klankbordgroep RADA project 13 april 2003 Farmacotherapeutic rational efficacy is reasonable safety is reasonable no obsolete components and ex-FNA (Formulary Dutch Pharmacists)-preparations (Dermatica op Recept) Chemical stability components Physical stability of the combination (Avoid adding agents to brand name products) Stability of the preparation User friendly (preferable in one tube)

16. BAK-Workshop 16-11-200716 Regional standardized (RA) preparations RA’s to fulfill the wishes of dermatologists RA’s follow the assessment criteria of non- standardized products  regional standardized products The stability of RA’s is 1 month untill research has proven a longer period of stability Compounding instructions for all RA’s on www.stevenshof.nl

17. BAK-Workshop 16-11-200717 Clobetasol 5% Salicylzuur in Dermovatezalf® Desoximethason 5% of 10% Salicylzuur in Topicorte® huidemulsie Hydrocortison 1% Hydrocortisonacetaat in ketoconazolcrème 1% Hydrocortison in propyleenglycol 5% Salicylzuur + 1% hydrocortisonacetaat in lanettesmeersel FNA 1% Hydrocortisonacetaat + 5% zwavel in lanettecrème I FNA 1% Hydrocortisonacetaat + 5% zwavel in lanettezalf FNA 1% Hydrocortisonacetaat + 5% zwavel in zinkoxidesmeersel FNA (+ 2% miconazolnitraat) 1% Hydrocortisonacetaat + 5% zwavel in zinkoxidezalf 10% FNA (+ 2% miconazolnitraat) Resorcinol 15% Resorcinol in lanettecrème I FNA 2% Resorcinol + 0,1% triamcinolonacetonide in lanettecrème I FNA 7,5% Resorcinol+ 7,5% salicylzuur (of 10%+10%; 12,5%+12,5% 15%+15%) in lanettecrème I FNA Tocopherol 5% of 10% Alpha-tocopherolacetaat in cetomacrogolcrème FNA Tretinoine 0,1% triamcinolonacetonide in tretinoïnecrème 0,05% FNA Triamcinolonacetonide 0,1% Triamcinolonacetonide in ketoconazolcrème 0,1% Triamcinolonacetonide in propyleenglycol 10% Salicylzuur + 0,1% triamcinolonacetonide in 75% basis voor lanettezalf FNA + 25% cetiol V 5%, 10% of 15% Salicylzuur + 0,1% triamcinolonacetonide in lanettesmeersel FNA 0,1% Triamcinolonacetonide + 40% propyleenglycol in cetomacrogolcrème FNA (eventueel + 20% vaseline) 0,1% Triamcinolonacetonide + 5% zwavel in zinkoxidesmeersel FNA (+2% miconazolnitraat) 0,1% Triamcinolonacetonide + 5% zwavel in zinkoxidezalf 10% FNA (+ 2% miconazolnitraat) Ureum 10% Ureum + 10% propyleenglycol in cetomacrogolcrème FNA Regional preparations (RA)

18. BAK-Workshop 16-11-200718 Diagnosis?

19. BAK-Workshop 16-11-200719 Dyshidrotic eczema= vesicular hand eczema RA (not first choice): 0.1% Triamcinolone acetonide with 2% resorcinol in lanette cream FNA

20. BAK-Workshop 16-11-200720 Products Make use of the decision tree and assessment criteria Regional formulary of rational ‘Magistralrezeptur’ 80% standardization on dispensing Dermatic bases and adds as assisting tool Compounding instructions for regional preparations (RA) Communicationplan with forms for dermatologist, general practitioners and pharmacists Courses and FTO (pharmacotherapeutic consultation) material

21. BAK-Workshop 16-11-200721 Regional Formulary

22. BAK-Workshop 16-11-200722 Dermatic bases and adds

23. BAK-Workshop 16-11-200723

24. BAK-Workshop 16-11-200724 Evaluation standardization

25. BAK-Workshop 16-11-200725 Evaluation implementation february 2006

26. BAK-Workshop 16-11-200726 Benefits patients, prescribers and compounders (Clear overview of) rational and high quality preparations Quick communication between prescriber and pharmacy possible Exact composition of preparations is known Uniform mode of compounding Preparation is available (within usual preparationtime) No unnecessary waiting time in the pharmacy for the patient FNA, LNA and regional preparations are reimbursed by the health insurance companies.

27. BAK-Workshop 16-11-200727 Take home message Mutual recognition voor each others’ knowledge and expertise and capacity of emotional experience in the other care member is essential for the succes of this kind of projects

28. BAK-Workshop 16-11-200728 For more information see www.stevenshof.nl