DefinitionThis section has been translated automatically.
Medical, dental or veterinary instructions to a pharmacy for the preparation of medicines. The doctor can thus individually select and combine the basis(powders, lotions, emulsions, creams, ointments, paste, liquid), the additives (possibly preservatives) and the active ingredients(antiseptics, antibiotics, antifungals, keratolytics, glucocorticoids) of the external therapy.
General informationThis section has been translated automatically.
The definition of the term prescription is derived in accordance with pharmaceutical terminology from the context of §§ 7, 8 and 9 AMG (German Medicines Act). An essential difference between the term prescription and bulk production is that the pharmacy must have a concrete order for the production of the respective prescription drug at the time of production. This can be done, for example, by prescription. From this it follows that a prescription is basically only to be understood as the individual production of pharmaceuticals. The term prescription is not explicitly used in the German Medicines Act. In contrast to the ready-to-use drugs defined in § 4 AMG, prescription drugs would be understood as drugs that are not manufactured and marketed in advance.
Notice! The production of medicinal products on prescription is only permitted in pharmacies.
The pharmacy is basically obliged to produce prescription drugs itself. This follows indirectly also from § 17.4 AMG, which prescribes that prescriptions must be carried out immediately. Justified exceptions should not be discussed further in this context. In principle, the pharmacist may only use ingredients in a prescription that have been prescribed. The pharmacist is expected to critically review the pharmaceutical-technological aspects of the formulation and to optimize the formulation by expert selection of suitable excipients.
Erroneous or questionable prescriptions:
The production of medicinal products according to prescription is not permitted if the prescription shows an obvious error, is illegible or if there are other concerns. The pharmacist may be expected to critically evaluate the composition of the preparation without being required to evaluate the therapeutic safety of the prescription. The pharmacist is also expected to check the chosen dosage. A manifest error is made, for example, if the upper indicative concentrations of the NRF for certain medicinal products are exceeded without this having been indicated in the prescription concerned.
It is often difficult to substantiate concerns about the composition of a prescription. A difficult situation may arise where the pharmacist's concerns about the use of certain substances or preparations are so serious that he feels he cannot justify placing them on the market. This would apply, for example, to the prescription of Sack's solution with benzene. Benzene has already been classified by the FOPH as a matter of concern.
Even if the concern only applies to finished medicinal products, the assessment of the Office must apply all the more to magistral prescriptions. This has the consequence that these may not be manufactured and dispensed by the pharmacist despite a corresponding prescription.
Appropriate information:The problem with
prescriptions is not solved by the appropriate information of the patient (problem with the package insert!).
Difficulty of quality assurance:
The ApBetrO (Apothekenbetriebsordnung) is based on the principle that the pharmacist is fully responsible for the proper quality of the medicines he produces and dispenses. The general obligation for comprehensive quality assurance of the drugs produced in the pharmacy is derived directly from this principle. However, the special situation in the production of a prescription requires the waiver of a comprehensive final product control. Such a control would hardly be feasible because of the small quantities involved and, above all, in view of the difficulties to be expected in developing a suitable analytical method.
Voluntary waiver by the physician:
When producing a prescription according to the pharmacopoeia or other contemporary collections of regulations,e.g.
New Prescription Form(NRF), it can be assumed that the production steps are largely validated so that the quality of the product is guaranteed by the production process.
Note(s)This section has been translated automatically.
Structure of the recipe
Inscriptio: Dr.med.XX, Dermatologist Place, street, number, telephone, date
Praescriptio: Ingredients or regulation designation
Signatura: S. Detailed instructions for use, with frequency and duration of use.