Regional Agreements on Dermatological Extemporaneous Preparations Dermatologische Magistralrezeptur: Erfahrungen und Empfehlungen aus Holland

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Regional Agreements on Dermatological
Extemporaneous PreparationsDermatologische
Magistralrezeptur Erfahrungen und Empfehlungen
aus Holland

• FTTO 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
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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

• RAs to fulfill the wishes of dermatologists
• RAs follow the assessment criteria of
  non-standardized products ? regional
  standardized products
• The stability of RAs is 1 month untill research
  has proven a longer period of stability
• Compounding instructions for all RAs on
  www.stevenshof.nl

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Regional preparations (RA)
Clobetasol 5 Salicylzuur in Dermovatezalf Desoxi
methason 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 1010
12,512,5 1515) 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 Triamcinolonacetoni
de 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 triamcinolonacetonid
e in lanettesmeersel FNA 0,1 Triamcinolonacetonid
e 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) Ureu
m 10 Ureum 10 propyleenglycol in
cetomacrogolcrème FNA
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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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Regional Formulary
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Dermatic bases and adds
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Evaluation standardization

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Evaluation implementation february 2006

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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