The same active constituents of medications are consistently used in Swiss perinatal centres for the main indications in pregnant women. Despite the existing experience and available evidence, they are mainly used off-label. Official authorisations for frequently or consistently used active ingredients should be granted.
Objectives: Opioid-free anesthesia is used increasingly often in hospitals around the world. In this type of anesthesia, opioids are replaced by other analgesics, such as ketamine, lidocaine, dexmedetomidine, and magnesium sulfate. Many clinicians prepare these agents as dual, triple, or quadruple admixtures within a single syringe. However, data on the stability of the individual substances within these preparations over time and in different storage conditions is very limited. Here, we aim to investigate various admixture of dexmedetomidine, ketamine, lidocaine, and magnesium sulfate with respect to the stability of the individual agents over time at different storage conditions. Methods: An ultra-high performance liquid chromatography method coupled to mass spectrometric detection was developed and validated to determine the stability of lidocaine, ketamine, and dexmedetomidine. Quantification of magnesium was carried out in parallel by potentiometric titration. Results: Our results demonstrate the stability of dual, triple or quadruple mixtures of selected substances in 0.9% saline under different storage conditions. Under all conditions, analyzed admixtures remain stable for at least 8 weeks. The quadruple mixture of lidocaine, ketamine, dexmedetomidine, and magnesium sulfate was storable for as long as 148 days without a significant loss of analyte. Conclusion: A new chromatographic method was successfully developed to analyze the stability of various pharmacological agents commonly used by clinicians in opioid-free anesthesia. The data we obtained indicate that mixing these agents together in a single syringe is safe and reliable and suggest that hospital pharmacies may prepare these solutions in advance of planned surgeries.
Background In order to improve the safety of drugs in pregnancy and lactation, it is imperative that data on clinical practice be collected and validated. Methods Data on routinely used medications were requested from 9 Swiss perinatal centres (5 university hospitals for obstetrics and 4 non-university centres). Furthermore, recommendations and guidelines from scientific societies for the fields of application were sought. Results Part II (lactation): For the lactation period, 48 different active substances were each identified by at least 4 centres. The active constituents most frequently cited by the centres were i. v. iron, lorazepam, nifedipine and paracetamol. Only a few guidelines were found that explicitly refer to the breastfeeding period. Therefore, fewer recommendations for use during lactation could be found compared with during pregnancy. Conclusion As with during pregnancy, the same active ingredients are consistently used in Swiss perinatal centres for many different indications during lactation. Most of these active ingredients are labelled with a warning or are even considered to be contraindicated; their use is therefore mainly off-label. Official authorisation for frequently or consistently used active substances is urgently needed. With this study, a first important step towards national harmonisation has been taken.
BackgroundThe medicine of pregnant women practices to a targeted personalized approach, tailored to the specific characteristics and needs the implications of interdisciplinary work between healthcare stakeholders. Perinatal pharmacology comprises the impact of substances (drugs, medications and others) in pregnant women, nursing mothers, the unborn child, the premature, the newborn baby and the breastfed baby. Most of the drugs are off-label used. In this field grand challenge for Frontiers in Medicine emphasizes the importance of translational medicine.AimThe primary goal of SAPP has always been and remains the same: it is the link between medicine and pharmacy, between practice, clinic, research and health authorities, in order to increase the safety of medicines in the population of pregnant and breastfeeding women and their newborns.1 MethodsOn December 6, 2007, an interdisciplinary team of 8 physicians and pharmacists founded the Swiss Association of Perinatal Pharmacology, SAPP. It collects and promotes new findings in the field of perinatal pharmacology.ResultsSpecialists from all areas of perinatal pharmacology work together in a scientific committee to develop and update evidence-based principles for work in everyday clinical practice (hospitals, doctor´s surgeries, pharmacies). Today, around 200 members benefit from this, who can orient themselves in regular further training courses and basic documents (monographs of active substances, therapy recommendations based on original literature). The SAPP thus closes the gap resulting from the predominant off-label use and the resulting lack of information on drugs in this population.ConclusionThe primary objective of SAPP has been achieved - it provides guidance for the practioners in the broad field of perinatal pharmacology and bridges the gap caused by the lack of drug approvals in this population. Long-term survival will be ensured by measures anchored in law.Referencewww.sappinfo.chDisclosure(s)Nothing to disclose
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