RESUMO
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.
Assuntos
Aleitamento Materno , Obstetrícia , Feminino , Humanos , Lactação , Gravidez , SuíçaRESUMO
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.
RESUMO
BACKGROUND: In order to improve the safety for drugs in pregnancy and lactation, data on the clinical practice must be collected and validated. METHODS: Data on the medications routinely used were requested from the university hospitals for obstetrics and the non-university perinatal centres in Switzerland and recommendations and guidelines of scientific societies for the various fields of application were sought. RESULTS: Part I: For during pregnancy and the peripartal period respectively, 69 and 21 different active constituents of medications were identified from at least 4 centres. For during pregnancy, the active constituents used in most of the centres are nifedipine, iron i. v. and oral, labetalol and magnesium sulphate, amoxicillin with clavulanic acid, paracetamol, dalteparine, metoclopramide as well as atosiban and hexoprenaline; for during the peripartal period betamethasone, misoprostol, oxytocin, clindamycin as well as fibrinogen, sulprostone and tranexamic acid were most frequently cited. Recommendations of various scientific societies were found primarily for pregnancy-specific fields of application. CONCLUSION: 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.