A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiency

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SALUS Haus GmbH & Co. KG

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01 Jul 2020·Zeitschrift für Gerontologie und GeriatrieQ4 · MEDICINE

Current status of regulatory requirements and clinical reality

Q4 · MEDICINE

Article

Author: Drey, Michael ; Gempel-Drey, Gabriele

BACKGROUNDGeriatric patients are the main users of medicinal products, although this patient group is most commonly excluded from clinical trials. Several guidelines from the International Conference on Harmonisation (ICH) and the European Medicines Agency (EMA) have tried to ensure the development and the safe use of medicines for geriatric patients.OBJECTIVEThis article aims to evaluate geriatric information provided by the summary of product characteristics (SmPC) to prescribers using relevant medicinal products in Germany for patients older than 65 years.MATERIAL AND METHODSBased on the annually published drug prescription report (Arzneiverordnungsreport), medication which was prescribed mainly (above 80%) or at a high defined daily dose (DDD [doses per day] > 400) to patients older than 65 years in 2016 was reviewed regarding relevant geriatric information.RESULTSThe average compliance for the investigated drugs regarding geriatric information according to EMA guidelines is 27%. At least older patients are mentioned in the SmPC most frequently (68%). Information about doses or dose adjustments for patients with certain stages of frailty was not provided by the pharmaceutical companies.CONCLUSIONCurrent information in the SmPC for a safe and effective use of medicines for older patients is insufficient and does not conform to EMA guidelines. Compared to drug authorization in pediatrics where the industry is obliged to submit a special pediatric investigation plan (PIP) to cover the needs of this certain patient group, a mandatory geriatric investigation plan (GIP) similar to the PIP would be an appropriate measure to provide safe and effective medicines for older patients.

01 Jan 2018·Pharmeuropa bio & scientific notes

Findings on the heavy metal content in herbal drugs and essential oils - an update.

Article

Author: Albert, H ; Steinhoff, B ; Klier, B ; Knödler, M

In this contribution, data for 7 elemental impurities originating from quality control analysis of manufacturers of herbal products is evaluated in light of the current requirements of the European Pharmacopoeia (Ph. Eur.) and the European legislative framework. The data shows that the Ph. Eur. limits set for cadmium, lead and mercury in herbal drugs are in principle still appropriate. The probability of herbal drugs exceeding the limits for arsenic, cobalt, nickel and vanadium (based on the ICH Q3D guideline for elemental impurities) appears to be very low, and consequently, it is proposed that general limits for these elements in herbal drugs in the Ph. Eur. are not required. For essential oils, there does not appear to be a risk of heavy metal contamination and a general test on heavy metals is not considered necessary.

01 Jan 2013·Pharmeuropa bio & scientific notes

The occurrence of bromide in herbal drugs: is there a need for a Ph. Eur. limit?

Article

Author: Busch, J ; Albert, H ; Steinhoff, B ; Kühn, M ; Klötzel, M ; Klier, B

This contribution provides an overview on the current legal requirements regarding limits for bromide and presents data on the actual bromide burden of commonly used herbal drugs. Evaluation of an extensive data base shows that results exceeding the limit of 50 mg/kg are found in specific plants which take up bromide to a high extent from the environment. Thus, positive findings of bromide in herbal drugs do not necessarily serve as a proof for methyl bromide treatment. Taking into account the ADI recommended by EMA and WHO, there are no toxicological concerns with regard to the intake of herbal teas, extracts or comminuted herbal drugs at therapeutic doses. Furthermore, the use of methyl bromide and other fumigants must be documented within the batch documentation. If stated in the batch documentation that no fumigation was carried out, it is not necessary to perform the test on bromide. In cases of a particular suspect and if toxicological concerns exist, additional testing can be performed in accordance with the limits set by Regulation (EC) No. 396/2005. For the above reasons, information obtained by performing the test on bromide is not significant for the assessment of quality. Therefore, it seems no longer necessary to maintain bromide in Ph. Eur. general chapter 2.8.13. Pesticide residues and it is recommended to delete it from Table 2.8.13.-1.

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