Phytopharmaceuticals are not interchangeable

Guideline of German pharmacists confirmed: Phytopharmaceuticals are not interchangeable

04/24/2014

In order to promote the use of cheaper counterfeit medicines, the legislator has called the so-called „Aut idem“-Regulation introduced. It provides that the pharmacist instead of a drug-formulated remedy to the patient a drug-like cheaper drug to hand over. For herbal medicinal products, this rule is only applicable in rare exceptional cases, the German Pharmaceutical Association (DPhG) states in its current guideline. Patients who are prescribed a certain herbal medicine by their doctor should therefore receive from the pharmacist exactly the preparation mentioned on the prescription.

The DPhG wants to use its guideline to help ensure that drug safety is ensured in the event of an exchange („substitution“) is not endangered between drugs of the same type and the legitimate interests of patients are preserved. The authors of the updated scientific guideline, all renowned drug researchers, state that: In the case of herbal medicines, the complex compound extract is the active ingredient. Depending on the manufacturing process, very different extracts can be produced based on a particular drug. For the decision whether a herbal medicinal product in the sense of „Aut idem“-Can not be replaced by another drug, so it is not sufficient that both products go back to the same vegetable raw material.

Extracts that differ in their extraction method and / or in the extractant used, according to the guideline, can not be considered as „Drug-identical“ can be viewed and therefore can not be exchanged. The general principle that modified dosage forms are not interchangeable also applies to herbal medicines.

The Munich-based Committee for Research Natural Medicine e.V. welcomes the clear statement of the DPhG. The new guideline confirms the view expressed by the KFN that in the case of complex herbal medicines, the „Aut idem“-Regulation is not applicable. The obvious reason: Even if they are made from the same plant, herbal medicines can be very different. Their effectiveness and compatibility depends on the quality of the plant material as well as on the nature of its processing. With the phytopharmacon, the doctor not only prescribed a specific medicinal plant, but a selected, scientifically researched extract with consistent quality and dosage. (Pm)