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The Difficulties in Antihypertensive Drug Prescription During Lactation: Is the Information Consistent?

ABSTRACT: The lack of consistent official information on the use of medications during lactation is probably one of the main reasons leading to an excess of prudence, based on presumption of risk rather than on evidence. The objective of this study was to compare the level of agreement between different official sources available to doctors and women on the use of medications during lactation.Sources of information included governmental regulatory agencies (RAs) and scientific sources (SS). The package leaflets (PLs) and summaries of product characteristics (SPCs) were retrieved from online databases of the European Union and U.S. RAs. Among the SS, the latest edition of the book Medications and Mothers' Milk by Hale and Rowe and the LactMed database were selected. Information about the use of 11 antihypertensive medications during breastfeeding was analyzed.The PLs and SPCs report a higher risk profile than the one expressed by SS, and they often suggest the interruption of lactation even for compatible medications.Health professionals should be supported by official, accurate, comprehensive, and consistent information about maternally ingested medication and breastfeeding management to facilitate proper decision-making.

SUBMITTER: Colaceci S

PROVIDER: S-EPMC4683560 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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The Difficulties in Antihypertensive Drug Prescription During Lactation: Is the Information Consistent?

Colaceci Sofia S Giusti Angela A Chapin Elise Merrill EM Notarangelo Micaela M De Angelis Alessia A Vellone Ercole E Alvaro Rosaria R

Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine 20151113 10

<h4>Introduction</h4>The lack of consistent official information on the use of medications during lactation is probably one of the main reasons leading to an excess of prudence, based on presumption of risk rather than on evidence. The objective of this study was to compare the level of agreement between different official sources available to doctors and women on the use of medications during lactation.<h4>Materials and methods</h4>Sources of information included governmental regulatory agencie ...[more]

PMID: 26565668

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Project description:BackgroundA lack of safety data on postpartum medication use presents a potential barrier to breastfeeding and may result in infant exposure to medications in breastmilk. The type and extent of medication use by lactating women requires investigation.MethodsData were collected from the CHILD Cohort Study which enrolled pregnant women across Canada between 2008 and 2012. Participants completed questionnaires regarding medications and non-prescription medications used and breastfeeding status at 3, 6 and 12 months postpartum. Medications, along with self-reported reasons for medication use, were categorized by ontologies [hierarchical controlled vocabulary] as part of a large-scale curation effort to enable more robust investigations of reasons for medication use.ResultsA total of 3542 mother-infant dyads were recruited to the CHILD study. Breastfeeding rates were 87.4%, 75.3%, 45.5% at 3, 6 and 12 months respectively. About 40% of women who were breastfeeding at 3 months used at least one prescription medication during the first three months postpartum; this proportion decreased over time to 29.5% % at 6 months and 32.8% at 12 months. The most commonly used prescription medication by breastfeeding women was domperidone at 3 months (9.0%, n = 229/2540) and 6 months (5.6%, n = 109/1948), and norethisterone at 12 months (4.1%, n = 48/1180). The vast majority of domperidone use by breastfeeding women (97.3%) was for lactation purposes which is off-label (signifying unapproved use of an approved medication). Non-prescription medications were more often used among breastfeeding than non-breastfeeding women (67.6% versus 48.9% at 3 months, p < 0.0001), The most commonly used non-prescription medications were multivitamins and Vitamin D at 3, 6 and 12 months postpartum.ConclusionsIn Canada, medication use is common postpartum; 40% of breastfeeding women use prescription medications in the first 3 months postpartum. A diverse range of medications were used, with many women taking more than one prescription and non-prescription medicines. The most commonly used prescription medication by breastfeeding women were domperidone for off-label lactation support, signalling a need for more data on the efficacy of domperidone for this indication. This data should inform research priorities and communication strategies developed to optimize care during lactation.

Project description:The aim of this study was to investigate the level of misunderstanding of medication information in Korean adults after stratifying by level of health literacy and to identify the factors influencing the misunderstanding of medication information and reading amounts of information on OTC drug labels. A cross-sectional survey was performed with 375 adult participants using the survey instrument. Multiple linear regression analyses were performed to identify factors which influence misunderstanding of medication information. Participants misunderstood 20% of words on OTC drug labels, 9% of prescription drug instructions, and 9% of pictograms. Participants on average read 59% of the overall contents of the OTC drug labels. As prescription drugs' dosing regimens became more complicated, the level of misunderstanding instructions increased. The level of misunderstanding words on OTC drug labels significantly decreased as participants had adequate health literacy (β = -18.11, p < 0.001) and higher education levels (β = -6.83, p < 0.001), after adjusting for the study variables. The level of misunderstanding instructions for prescription drugs increased as participants became older (β = 8.81, p < 0.001) and had lower education levels (β = -5.05, p < 0.001), after adjusting for the study variables. The level of misunderstanding pictograms was similar to that of misunderstanding instructions for prescription drug labels. The amount of reading information on OTC drug labels significantly increased as respondents had adequate health literacy (β = 9.27, p < 0.001), were older (β = 12.49, p < 0.001), or had chronic diseases (β = 7.49, p = 0.007). Individuals' health literacy level, reading behaviors, and complexity of medication instructions are associated with misunderstanding of medication information. Appropriate word choices in drug labels and an improved format of medication instructions could increase understanding of medication information and prevent adverse drug reactions.

Project description:ImportancePreventive drugs are often underused. Carotid intima-media thickness and carotid plaques are associated with cardiovascular disease (CVD), and their detection could possibly improve estimation of the likelihood of CVD and prescription of preventive drugs.ObjectiveTo evaluate whether pictorial information on participants' asymptomatic atherosclerosis based on carotid ultrasonographic examinations to participants and their physicians had an effect on prescribing of lipid-lowering or antihypertensive drugs during the following 465 days.Design, setting, and participantsVisualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention is a pragmatic randomized clinical trial nested within the Västerbotten Intervention Program, a CVD screening and prevention program in Sweden with 60% to 70% participation rates and small social selection bias. A total of 4177 individuals aged 40, 50, or 60 years participating in the Västerbotten Intervention Program who had low to moderate risk of CVD were invited to enroll in this trial from April 29, 2013, to June 7, 2016. Prescriptions for all participants were monitored for 465 days after the intervention. Data analysis was conducted from December 6, 2019, to April 2, 2020.InterventionsParticipants and their family physicians were randomly assigned 1:1 to receive or not receive pictorial information from carotid ultrasonographic determination of vascular age, assessed as carotid intima-media thickness and the presence of carotid plaques, combined with a follow-up call to participants by nurses.Main outcomes and measuresTwo outcome measures of prescriptions of antihypertensive and lipid-lowering drugs within 465 days after ultrasonography was performed. Data obtained through intention-to-treat analysis are presented as proportions of individuals with a prescription among those who had no baseline prescription for agents from these drug classes.ResultsOf the 4177 individuals invited to enroll, 3532 participants were randomized and included in the analysis; 1870 (52.9%) were women, 2278 (64.5%) were aged 60 years, 978 (27.7%) were 50 years, and 276 (7.8%) were 40 years. First prescriptions of lipid-lowering drugs were higher in the intervention group vs the control group among men (118 of 639 [18.5%] vs 38 of 692 [5.5%]; P < .001) and women (126 of 804 [15.5%] vs 38 of 817 [4.7%]; P < .001). There were no significant differences in the proportion with prescription of antihypertensive drugs in the intervention vs control groups after ultrasonography among men (58 of 482 [12.0%] vs 56 of 528 [10.6%]; P = .47) and women (60 of 612 [9.8%] vs 64 of 615 [10.4%]; P = .73).Conclusions and relevanceThe findings of this trial demonstrate that provision of pictorial information on vascular age and carotid plaques based on the results of ultrasonographic examination increased physician prescription of lipid-lowering drugs but not antihypertensive drugs within the following 465 days.Trial registrationClinicalTrials.gov Identifier: NCT01849575.

Project description:BackgroundThe ICH E7 guideline intends to improve the knowledge about medicines in geriatric patients. As a legislative document, it might not reflect the needs of healthcare professionals. This study investigated what information healthcare professionals, regulatory agencies and pharmaceutical industries consider necessary for rational drug prescribing to older individuals.Methods and findingsA 29-item-questionnaire was composed, considering the representation in trials, pharmacokinetics, efficacy, safety, and convenience of use in older individuals, with space for additions. Forty-three European professionals with an interest in medication for older individuals were included. In order to investigate their relevance, five items were included in a second questionnaire, with 11 control items. Median scores, differences between clinical and non-clinical respondents and response consistency were analysed. Consistency was present in 10 control items. Therefore, all items of the first questionnaire and the five additional items were analysed. Thirty-seven (86%) respondents returned the first questionnaire; 31/37 (84%) the second. Information about age-related differences in adverse events, locomotor effects, drug-disease interactions, dosing instructions, and information about the proportion of included 65+ patients was considered necessary by most respondents. Clinicians considered information significantly more important than the non-clinical respondents about the inclusion of 75+, time-until-benefit in older people, anticholinergic effects, drug-disease interactions, and convenience of use. Main study limitations are the focus on information for daily practice, while the ICH E7 guideline is a legislative document focused on market approval of a new medicine. Also, a questionnaire with a Likert scale has its limitations; this was addressed by providing space for comments.ConclusionsThis study reveals that items considered necessary are currently not included in the ICH E7 guideline. Also, clinicians' and non-clinicians' opinions differed significantly in 15% of the items. Therefore, all stakeholders should collaborate to improve the availability of information for the rational prescribing to older individuals.

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The Difficulties in Antihypertensive Drug Prescription During Lactation: Is the Information Consistent?

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The Difficulties in Antihypertensive Drug Prescription During Lactation: Is the Information Consistent?

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