Regional Agreements on Dermatological Extemporaneous Preparations

Dermatologische Magistralrezeptur: Erfahrungen und Empfehlungen aus HollandFTTO RADA Leiden e.o.

Annemieke Floor-Schreudering

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Content

• Motivation for starting the project• Introduction• Problems• Aims • Methods• Assessment ‘Magistralrezeptur’• Regional standardized preparations• Products• Evaluation

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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

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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

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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

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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

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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

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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

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Do you believe the efficacy of the

preparations prescribed or

dispensed by yourself is

convincing?

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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

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Do you prescribe or dispense

brand name products with an

extra component?

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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.”

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Decisiontree dermatological preparationsApproved 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

yes

no

Choose this national standardized product

Is a regional standardized product available? yes Choose this regional standardized product

yesChoose this product

no

no

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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)

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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

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Clobetasol5% Salicylzuur in Dermovatezalf®Desoximethason5% of 10% Salicylzuur in Topicorte® huidemulsieHydrocortison1% Hydrocortisonacetaat in ketoconazolcrème1% Hydrocortison in propyleenglycol5% Salicylzuur + 1% hydrocortisonacetaat in lanettesmeersel FNA1% Hydrocortisonacetaat + 5% zwavel in lanettecrème I FNA1% Hydrocortisonacetaat + 5% zwavel in lanettezalf FNA1% Hydrocortisonacetaat + 5% zwavel in zinkoxidesmeersel FNA (+ 2% miconazolnitraat)1% Hydrocortisonacetaat + 5% zwavel in zinkoxidezalf 10% FNA (+ 2% miconazolnitraat)Resorcinol15% Resorcinol in lanettecrème I FNA2% Resorcinol + 0,1% triamcinolonacetonide in lanettecrème I FNA7,5% Resorcinol+ 7,5% salicylzuur (of 10%+10%; 12,5%+12,5% 15%+15%) in lanettecrème I FNATocopherol5% of 10% Alpha-tocopherolacetaat in cetomacrogolcrème FNATretinoine0,1% triamcinolonacetonide in tretinoïnecrème 0,05% FNATriamcinolonacetonide0,1% Triamcinolonacetonide in ketoconazolcrème0,1% Triamcinolonacetonide in propyleenglycol10% Salicylzuur + 0,1% triamcinolonacetonide in 75% basis voor lanettezalf FNA + 25% cetiol V5%, 10% of 15% Salicylzuur + 0,1% triamcinolonacetonide in lanettesmeersel FNA0,1% 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)Ureum10% Ureum + 10% propyleenglycol in cetomacrogolcrème FNA

Regional preparations (RA)

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Diagnosis?

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Dyshidrotic eczema= vesicular hand eczema

RA (not first choice): 0.1% Triamcinolone acetonide

with 2% resorcinol in lanette cream FNA

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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

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Werkzame stof Code Bestanddelen Bijzonderheden Allantoine Obsoleet

HP Aluminiumacetotartraatoplossing FNA 1:10 verdunnen Aluinstrooipoeder, samengesteld FNA Aluminiumchlorideoplossing 20% FNA Aluminiumhydroxychloride 20% in cetomacrogolcrème FNA

Aluminium-zouten FNA

Aluminiumhydroxychlorideoplossing 15% FNA Azelaïnezuur FNA 20% Azelaïnezuur in lanettecrème I FNA

Benzoëzuursalicylzuurcrème FNA (Whitfield's crème FNA) Benzoëzuursalicylzuuroplossing FNA (Whitfield's oplossing FNA)

Benzoëzuur FNA

Benzoëzuursalicylzuurzalf FNA (Whitfield's zalf FNA) Benzylbenzoaat FNA Benzylbenzoaatsmeersel 25% FNA Betamethason HP Calamine Calamineschudsel FNA Calciumgluconaat FNA 2,5% Calciumgluconaat+ 0,5% chloorhexidinedigluconaat in gel

(Calciumgluconaatgel 2,5% FNA)

Capsaicine FNA 0,025% of 0,075% Capsaicine in lanettecrème I FNA Chlooramfenicol Obsoleet

HP Chloorhexidinedigluconaatcrème 1% FNA Chloorhexidinedigluconaatmondspoeling 0,2% FNA Chloorhexidinedigluconaatoplossing 0,5%, alcoholisch FNA Chloorhexidinedigluconaatoplossing 1% steriel FNA Chloorhexidinedigluconaatspoeling 0,1% FNA, gesteriliseerd Voor wondspoeling Chloorhexidinedigluconaatspoeling 0,02% FNA, gesteriliseerd Voor blaas- en vaginaalspoeling 1% Chloorhexidinedigluconaat in zinkoxidekalkwaterzalf FNA 1% Hydrocortisonacetaat in chloorhexidinedigluconaatcrème 1% FNA 0,1%Triamcinolonacetonide in chloorhexidinedigluconaatcrème 1% FNA

Chloorhexidine FNA

2,5% Calciumgluconaat+ 0,5% chloorhexidinedigluconaat in gel (Calciumgluconaatgel 2,5% FNA)

Ciclopirox HP HP

Clindamycinehydrochlorideoplossing 1% FNA 1% Clindamycinehydrochloride in carbomeerwatergel FNA

Clindamycine FNA

2% Clindamycinehydrochloride in cetomacrogolcrème FNA Clioquinol Obsoleet Clobetasol HP

Regional Formulary

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Dermatic bases and adds

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Evaluation standardization

Results effectmeasurement Base line

(september 2002)

Effect (januari –februari

2005)

Number of participating pharmacies 28 20

Number of dermatological prescriptions 542 329

Number of dermatological compounded medicines 157 66

Average number of dermatological compounded medicines per pharmacy 5.8 3.3

Dermatological compounded medicines/ total number of dermatological prescriptions 29.0% 20.1%

Dermatological prescription is prescribed according to regional formulary 79.0% (n=260)

Dermatological compounded medicine is dispensed according to regional formulary 74.2% (n=49)

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Evaluation implementation february 2006

Product yes no missing

Formulary is known (n=79) 96.2% 3.8% -

Formulary is used in daily practice (n=79) 59.2% 38.2% 2.6%

Dermatic bases and adds is used (n=79) 48.7% 47.4% 3.9%

Pharmacists use compounding instructions (n=30) 66.7% 26.7% 6.7%

Communicationplan is known (n=79) 67.1% 31.6% 1.3%

Consultationforms are used by prescribers (n=21) 4.8% 90.5% 4.8%

Consultationforms are used by pharmacists (n=25) 28.0% 68.0% 4.0%

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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.

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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

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For more information see

www.stevenshof.nl