Development of the First Clinical Classification of Medications Used during Lactation and the Evaluation of 1380 Drugs (original) (raw)
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RISK CLASSIFICATIONS OF MEDICINAL PRODUCTS PRESCRIPTED TO INTERNAL LACTANTS IN THE MATERNITY OF A UNIVERSITY HOSPITAL (Atena Editora), 2021
The use of medication by women during breastfeeding is a very common and growing practice in all stages of lactation and is among the factors most associated with early and abrupt weaning. This article presents a comparative analysis of risk classifications on medications used during lactation, identifying the most prescribed medications for breastfeeding women in a university hospital. For this, an observational, cross-sectional and descriptive study of the prescriptions of medications from the maternity hospital felt to the pharmacy sector during the months of September and October 2019 was carried out. Of the 507 prescriptions analyzed, 81 different types of medication were identified, with an average of 7, 24 medications / prescription. The prevalent prevalence of the therapeutic class was 16.28% of analgesics and 15.21% of antiemetics and antinauseants. According to the classification presented by the Ministry of Health, among the different types of medication observed in the study, 72.84% (n = 59) were classified as "compatible", 27.16% (n = 33) as "judicious" and no drug was identified as “contraindicated”, if used during lactation. However, according to the international classification consulted, only 29.63% (n = 24) of these were categorized as “compatible”. This divergence of results between the consulted databases indicates the importance of constantly updating the literature used by health professionals and the need to standardize the information provided to the patient, with a view to promoting safety during the use of medications and the breastfeeding process.
PubMed, 2019
It is important for healthcare professionals and pregnant women to have knowledge of the risks of using medicines during pregnancy and lactation. This not only concerns the influence of the medicinal product on the pregnant woman and the pregnancy, but also its impact on the growth and development of the (unborn) child, neonatal adaptation, possible precautions regarding child-birth, drug excretion in breast milk, and the short-term and long-term consequences for the newborn child. At present, information and advices are often fragmentary, sometimes contradictory, not easily accessible, or even not available at all. It is high time for one independent source to provide unambiguous, scientifically substantiated information and advice, accessible to both healthcare professionals and pregnant women - preferably in a digital format.
Characteristics of medication use during lactation
Journal of Human Growth and Development, 2018
Introdução: É inquestionável a importância do aleitamento materno. Seus benefícios abrangem o lactente, a nutriz, a família e a sociedade. A Organização Mundial de Saúde preconiza o aleitamento exclusivo até os seis meses de idade, o qual pode ser comprometido por alguns motivos, dentre eles o uso de medicamentos. Objetivo: Caracterizar os medicamentos utilizados por nutrizes, no que se refere a: categorias de risco; locais e responsáveis pela prescrição médica e orientações recebidas. Método: estudo transversal, retrospectivo, quantitativo. Os dados foram coletados na Estratégia de Saúde da Família (ESF) com 161 nutrizes nos anos de 2012 e 2013, por meio de questionário estruturado, contendo informações sobre o uso de medicamentos durante a lactação. Os dados foram apresentados em frequências absolutas e relativas, e comparados às variáveis selecionadas no estudo para verificação da existência de associação, utilizando-se o Teste do Qui-quadrado. Resultados: 55,9% das entrevistadas...
Lactation Safety Recommendations and Reliability Compared in 10 Medication Resources
Annals of Pharmacotherapy, 2007
Background: Discontinuation of breast-feeding is linked with an increased risk of acute and chronic diseases in children, as well as increased risk of maternal disease. Mothers and physicians often depend on pharmacists for accurate drug information. Their information is only as good as the sources available to them. Objective: To determine the reliability of safety recommendations for drugs used during lactation, based on current research and information, and determine whether resources may be inappropriately advising the interruption of breastfeeding. Methods: A comparison of 10 frequently used sources for information on medication used during breast-feeding was done for 14 commonly used drugs. Our sources included the databases used by 2 retail pharmacy chains, available text references, and electronic references. We assessed the number of drugs thought to be safe in breast-feeding for each source. The drugs reviewed included those widely accepted as safe, widely regarded as not ...
British Journal of Clinical Pharmacology, 2020
Funding information College ter Beoordeling van Geneesmiddelen Aims: The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and postauthorization data. Methods: Initial and post-authorization data were extracted from the European Public Assessment Reports and the latest versions of Summary of Product Characteristics using publicly available documents on the European Medicines Agency's website. Four sections were categorized regarding pregnancy outcomes: pre-clinical/animal studies, human female fertility, pregnancy-related outcomes and congenital malformations in the human fetus. Three sections were categorized regarding lactation outcomes: pre-clinical/animal studies, excretion in human breast milk and absorption in children through breastfeeding. The clinical applicability of each category was scored by specified criteria, based on scientific literature, and further as defined by the authors. Results: For the 16 included biologics, post-authorization data were delivered only for adalimumab, certolizumab pegol, etanercept and infliximab. For the 12 remaining biologics limited data on pregnancy and lactation during the post-marketing period of 2-21 years were available. Conclusions: In this article several suggestions are provided for improving a multidisciplinary approach to these issues. The initiation of suitable registries by marketing authorization holders and data transparency for clinicians and academics are highly endorsed.
2022
Lack of information about medication intake, transfer and safety is a major risk to breastfeeding continuity. The fear of using drugs during lactation, especially newer ones, opts physicians to discontinue breastfeeding. A knowledge of the principles of drug passage into human breastmilk (HBM) can guide lactation consultants to mediate the consultations between the mother and her treating physician. Scientists have previously used preclinical rodent models for the determination of drug excretion into milk, but these are very unreliable because of marked differences in milk composition and transporters compared to those of humans. Measurement of the drug levels in humans remains the gold standard. Experimental testing in animals and computer modeling using high exposure cutoffs can also be used to predict safety.
EAS Journal of Pharmacy and Pharmacology
Mothers during lactation may encounter barriers including the need of medication intake due to a chronic or acute illness, which may affect mainly the duration of breastfeeding. In these cases, the issue of medication safety during lactation arises and maternal decisions usually depend on professional counseling. Providing scientifically valid information on the benefits of breastfeeding and the risk of exposure of the newborn/infant to medicines through breast milk is a responsibility of healthcare professionals. Reliable sources on the compatibility of medicines with breastfeeding vary and the information among them is conflicting or even insufficient, creating as a consequence difficulty for healthcare professionals to provide counseling. Given the fact that breastfeeding mothers are excluded from clinical trials as they are considered a vulnerable population, the scientific community has turned to alternative methods based on pharmacokinetic population modeling for medication sa...
Safe Medicine Administration Counseling for Pregnant and Breastfeeding Mothers
ABDIMAS: Jurnal Pengabdian Masyarakat, 2022
The use of drugs for pregnancy and breastfeeding needs to be self-medication and the importance of counselling to increase the mother's knowledge about the correct use of drugs so that pregnant and lactating women's level of health and knowledge increases. The counselling purpose was to determine the mother's level of knowledge and whether there was a difference in the knowledge level of the use of drugs during pregnancy and lactation. The method used is pre and post-media analysis (flipchart). Data analysis obtain by scoring questionnaires, univariate analysis, and statistical analysis. Mann-Whitney test results showed that in the post-test or after giving counselling using flipchart media, there was a change in respondents' knowledge from before being given a flipchart and after being given a flipchart. The hypothesis from this counselling is accepted, which means that giving flipcharts affects the level of knowledge. The calculations using the spearman test obtain...
Vol. 2, Issue 12, December 2014, PharmaTutor, Paper-16.pdf
When pregnant mother consumes drugs it reaches the fetus through the placenta, in the same way that oxygen & nutrients are delivered to the baby in the mother's uterus. Depending upon the drug taken, the amount, duration & stage of pregnancy, it can produce varying effects on growing baby. Drugs can damage the fetus &cause developmental abnormalities (producing birth defects) & result in still birth. The objectives of the study were to assess the knowledge regarding teratogenic effect of drugs among staff nurse working in maternity and pediatric wards. Structured Knowledge Questionnaire on teratogenic effects of drugs was used to evaluate the knowledge of Staff Nurses. The results revealed that out of 30 staff nurses selected for the study, majority 19 (63.3%) possessed average knowledge regarding teratogenic effect of drugs.
Journal of Women's Health, 2005
Questions about medication use during pregnancy and lactation are a concern for women and healthcare providers. Unfortunately, there is little experience with the use of most medications in human pregnancy and lactation at the time they are marketed. Even when information is available, it may not be readily accessible to women and healthcare providers. Nevertheless, medication use by pregnant and breastfeeding women may be beneficial, and even essential, to ensure the health of both mother and child. In addition, almost half of pregnancies in the United States each year are unintended, and medication exposures may occur in the early weeks of gestation before a pregnancy is recognized. For these reasons, it is critical that up-to-date information about the effects of medication use during pregnancy and lactation and the management of maternal conditions be available to women and healthcare providers. A comprehensive, coordinated public health approach that builds on and expands existing activities is needed to generate information about medication use, make that information readily available, and translate it into safe and effective healthcare. Critical components of this system include a central source of up-to-date information, further development and coordination of monitoring and research activities, the availability of counseling services throughout the country, development of standard communication messages, and a panel of experts to provide oversight. This will require collaborative support from government agencies, nonprofit organizations, academic and public health professionals, and healthcare providers to ensure safe and beneficial use of medications during pregnancy and lactation.