Organ of the
GD Society for Dermopharmacy
Aut-idem-Regulation with Dermatological Preparations
Through publication in the Bundesgesetzblatt (Official Federal Gazette), the Arzneimittelausgaben-Begrenzungsgesetz (AABG) (Drug-Expenditure-Restriction Act) came into force in Germany on 23 February 2002. This act provides among other issues the so-called Aut-idem-regulation. Accordingly, pharmacies have to dispense a lower-priced drug of the same active substance in lieu of the prescribed one if the physician himself does not prescribe a low-priced drug (within the lower third of the price segment) on condition that "it is identical with the prescribed drug as to effective strength and pack size as well as authorized for the same indication sector and moreover has the same or interchangeable form of presentation" (SGB V, § 129, chapter 1). The Gesellschaft für Dermopharmazie takes the view that drugs for external application should be subject to exemption from this regulation.
In a press review concerning the AABG of 1 March 2002 (www.bmgesundheit.de/presse) the Bundesministerium für Gesundheit (Federal Ministry of Health) refers to the fact that already before the coming-into-force of the act, the physician could make an Aut-idem order by marking correspondingly with a cross on the prescription form and the pharmacist could dispense a drug containing the same active substances during his emergency duty in case of unavailability of the prescribed drug. Further, an emphasis is made on the fact that a general Aut-idem regulation is already in force and practised without difficulties in eight other countries, including France and Switzerland.
The regulation passed is considered to be a general regulation of the drug exchange also for dermatics, i.e. drugs for the treatment of skin diseases. In view of presentation form and type of application, a basic distinction of dermatics has to be made in systemical and topical products. The same considerations apply to systemical dermatics in the given context as to other systemical drugs. However, the situation is substantially different with drugs for topical applications, also called dermatics in a narrower sense. Drugs for topical application are mainly used in dermatology but also in other special fields as ear, nose and throat medicine and ophthalmology.
Special Characteristics of the Vehicle
Special attention is to be paid with drugs for topical application to the so-called vehicle. Skin and skin-near mucous membranes are by nature bordery organs to the major tasks of which it belongs to prevent the penetrating of foreign substances. This is why, it is far more difficult following a topical application at skin and skin-near mucous membranes to provide the absorption of drugs compared with internal mucous membranes as for instance the intestine mucous membrane, the main task of which consists of the absorption of foreign substances. As a rule, the absorption of active substances at local application is considerably lower than with peroral intake: thus with many systemical products it can be proceeded from an absorption of at least 90 percent of the supplied active substance whereas the absorption rate of drugs for topical application frequently lies in the one-digit percent area. The latter especially applies to the very frequently used topically glucocorticoids.
The question whether a sufficient absorption of the medicinal preparations after topical application has been effected, depends to a very large extent on the special composition of the respective vehicle whose structure regularly consists of a series of different components. Details regarding the form of a drug as for example ointment or cream merely represent an orientation: at the same active and also medicinal agent content, an ointment or cream base can be composed in a completely different manner. Hereby the release of the medicinal agent from the base, its absorption in skin and thus the therapeutical effectiveness of the drug can be influenced.
Moreover, vehicles develop - concerning the overall effect of the drug for topical application - a wanted intrinsic effect with many skin diseases that can assume a varying degree even at slight differences in the composition. If for instance hydrocortisone-containing drugs for topical application are used for the treatment of the atopical eczema, it can be assumed that the intrinsic effect of the bases referring to the overall effect of the respective product lies in the two-digit percent area.
Problem of therapeutical Equivalence
Therefore, varying from the perorally administered drugs, biopharmaceutical analyses are not considered to be sufficient for the establishing of the therapeutical equivalence in Europe. This is why, new generics for topical application always have to be characterized by a clinical effectiveness proof as condition for obtaining an authorization. In this context, it is of substantial significance that all drugs for topical application have not yet been authorized in Germany on the basis of an effectiveness proof. Now as ever, numerous preparations as so-called fictitiously authorized drugs are in circulation. Thus for example it does not apply to hydrocortisone-containing drugs for topical application on a general basis that the clinical effectiveness exceeds the intrinsic effect of the base. This however, represents a fundamental requirement to drugs for topical application that are filed for obtaining a new authorization and this is undoubtedly accomplished by certain hydrocortisone-containing drugs for external application.
Aspect of Tolerance
The complex composition of most drugs for topical application is also significant under the aspect of tolerance: especially with patients suffering from skin diseases at times a contact allergy on single substances of drugs for topical application is the case. It belongs to the most important tasks of the physician and in particular the dermatologist to select products in his prescription that will probably be well tolerated by the patient. In this context special importance is to be attached, if so possible, to the absence of allergens in the prescribed product identified in earlier epicutanaeous tests. A further problem with drugs for topical application lies in the fact that they are frequently available in form of quite special galenic systems. Even with identical qualitative composition of two products, there can be differences in the structure of the galenic system that are able to entail different biological effects.
No Substitution with Drugs for topical Application
Thus, the Gesellschaft für Dermopharmazie takes the view that it cannot be reasonable to declare a substitution of a prescribed drug for topical application as feasible only because prescribed and dispensed drug correspond in effective strength and pack size, it is authorized for the same indication area and available in "equal or exchangeable" presentation form. Even if two products with the same active substance in the same strength and the same presentation form (for example as ointment or cream) are declared accordingly, this fact is not able to justify the comparability, as explained above. Equivalence investigations regarding the effectiveness of active-substance-identical drugs for topical application are only available to a minor extent so that the pharmacist cannot rely on them in a satisfactory manner when dispensing a drug.
Expressly it is emphasized that the Gesellschaft für Dermopharmazie considers the necessity of economic efficiency in the legal health insurance as indispensable. This present statement is therefore not questioning the usefulness of an Aut-idem regulation in the legal health insurance in general. Concluding however, special emphasis is attached on the fact that drugs for topical application should explicitly be exempted from the Aut-idem regulation provided by the legislator.
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