Is it compatible with breastfeeding? www.e-lactancia.org: Analysis of visits, user profile and most visited products

Introduction: One of the factors to influence abandoning breastfeeding is mothers’ use of medications. The www. e-lactancia.org website is a reliable source in Spanish and English for online free-access information about the compatibility of medications with breastfeeding. The aim of this study was to analyse the search profiles


Introduction
Non-compliance with the current World Health Organization (WHO) recommendations on breastfeeding (BF), as fewer than 40 % of infants younger than 6 months old exclusively receive breast milk as food [1], poses a health risk for mothers and infants due to the innumerable benefits of breast milk as a protective factor against various infections [2], cancers [3] and other diseases [4] in newborns and infants.Regarding maternal health, BF promotes weight loss after childbirth [5], prolongs amenorrhea and reduces risks of breast and ovarian cancer, type 2 diabetes and cardiovascular disease [6].BF improves the health of mothers and babies worldwide [7].
Computer science, new technologies, physiological processes and daily life currently overlap to the extent that there is constant healthrelated information and learning sites on every website part.BF has not escaped this condition as many mothers seek information about BF for their babies on the website [18].
The Global Digital Report 2018 [19] revealed that more than 4 billion people worldwide use the Internet; i.e., more than half of the world's population is online, and almost 250 million new users were connected for the first time in 2017.The use of social media continues to grow rapidly.Mmore than 3 billion people use it every month, and 9 in every 10 users employ mobile devices.As noted by Andrew Arnold, "Parents have always sought out advice from others.Some generations looked to their parents and grandparents.Others relied on books from experts like Benjamin Spock.Today, 71 % of millennials value the advice and insights they receive from parenting blogs, parenting web sites, forums, and social networks" [20].
Therefore, the combination of new technologies and social media can influence BF rates.Health professionals also seek information on the website, whose main common reason for using and retrieving information online is to bridge a knowledge gap [21,22].
In this article, the e-Health counselling tool www.e-lactancia.orgwas studied based on health products with BF in order to analyse the search profiles and groups and products that are most searched on this website.

Materials and methods
A retrospective, comparative and descriptive study was conducted of the data recorded by the e-Health e-lactancia.orgtool from 01.01.2014 to 31.12.2018(5 full years).
This tool was conceived due to the dispersion of information on BF compatibility with taking drugs and medicinal plants, exposure to environmental pollutants or maternal diseases.It was created in 2000 in the Paediatric Service of a hospital that had obtained the UNICEF Baby Friendly Initiative accreditation in 1999 as a small database for using the service.For convenience purposes, it was uploaded to the Internet in 2002 and has grown since then with 1866 different products belonging to 192 groups, 8332 synonyms and 17,698 commercial brands (from the Martindale list), although the database is linked with active ingredients.e-lactancia.orgcontains 28,088 index terms.
The e-lactancia.orgwebsite has been recognised by prestigious organisations like the Academy of Breastfeeding Medicine, which has recommended it in several of its articles and protocols [23,24], La Leche League, iHan, the Grecia-Institute of Child's Health in Greece, the National Confederation of Pediatrics (Confederación Nacional de Pediatría −CONAPEME) and the Breastfeeding Association (Asociación Pro Lactancia Materna -APROLAM) in Mexico.
The e-lactancia.orgwebsite is composed of a search engine with which the inquiring person can input the term with which (s)he intends to assess compatibility with BF.The database returns a response, including an explanatory comment and some pharmacokinetic data, both based on the scientific literature, which are periodically updated and reviewed in each researched product, disease or medication.In addition, the response classifies the risk and compatibility of BF in relation to the searched product with the following easily interpretable colourcode.
• Green-Very low risk: safe product, compatible with BF with suffi- cient information published in the scientific literature or with more than one of the following characteristics: lack of demonstrated toxicity; frequent use in neonates or small infants with no side effects; extensive regular or traditional consumption; very favourable pharmacokinetics; consensus of experts.
• Amber-Low risk: quite safe and most likely compatible.Its use could have very mild adverse effects on BF or lactation.The physicochemical and pharmacokinetic characteristics of product absorption, distribution and elimination mean that the appearance of adverse effects is very unlikely; such data have either been reported or do not exist.
Use a safer alternative or interrupt BF for several T½ periods (elimination half-life).Products considered high risk are those that could have moderate or severe adverse effects on BF or lactation.The physico-chemical and pharmacokinetic characteristics of product absorption, distribution and elimination mean that the appearance of adverse effects is very unlikely; such data have either been reported or do not exist.
• Red-Very high risk: very unsafe.Contraindicated.Use an alternative or cease BF.The T½ of the drug is too long to consider temporary BF interruption an alternative.Due to published data or the characteristics of the substance, a high probability of it being toxic to the infant or detrimental to lactation by inhibiting it is known or assumed.
Each product can be searched directly by either its name or the group to which it belongs, or by its trademark, a synonym and other names in other scripts.When the product presents a high or a very high risk, possible alternatives that are more compatible with BF (if any) are presented through the same search.e-lactancia.org is regularly updated by the APILAM group (Association for the Promotion and Scientific and Cultural Research of Breastfeeding), a non-profit association.This website is supported mainly by voluntary donations from mothers, healthcare providers and breastfeeding support groups, and also by teaming groups.APILAM is formed by four paediatricians, three pharmacists and one nurse.It updates the database in several ways: when a new alert is received from a database (mainly PubMed); when a user writes to propose an update; systematically when the 100 most visited products are updated.

Data collection and analysis
The Google Analytics tool was used for data collection.This tool does not contain any personal data or confidential information, and comes as aggregated data [25].Among the variables that can be collected through Google Analytics, and which were analysed globally and disaggregated by year, we find: number of users, numbers of accesses and queries, access languages, subcontinents and countries from which access occurs, type of electronic device through which access is gained (computer, tablet, mobile), professional user profile.Moreover, there are sources of origin of the search and products about which user is informed on the website: drugs, therapeutic groups, phytotherapy and alternative products, contaminants and diseases.The level of risk assigned in e-lactancia.orgwas added to each analysed product.
A descriptive analysis was performed for all the variables using absolute and relative frequencies expressed as percentages.The pairwise differences in years were calculated for devices and access channels by the chi-square test.

Results
Table 1 shows how the number of users of e-lactancia.orgincreased year by year between 2014 and 2018, and went from 1.13 million in 2014 to 6.18 million in 2018.The numbers of sessions and page views also rose.The total number of users during the study period (2014-2018) was 16.8 million, with 63.8 million page views.
The access channels to e-lactancia.orgwere through "organic" searches (not paid) on search engines (62.1 %), by direct URLs (23.8 %), from social networks (8.2 %) and through links from other websites (5.8 %), with mobile phones (73.4 %) as the most widely used access device, followed by personal computers (22.6 %) and tablets (4.0 %).Tables 2 and 3 show the annual increases between 2014 and 2018 of mobile phones as an access device to e-lactancia.organd of "organic" searches as an access channel, respectively.Statistically significant differences were found between all the pairs of years analysed by devices and access channels (p < 0.05).
Product queries on the website came to 30,623,967.Table 4 shows the numbers and percentages of the most researched groups.

Discussion
The e-lactancia.orgtool very significantly increased as far as users are concerned from year to year: the number of visits increased 10-fold from 2014 to 2018.
One of the factors to explain these millions of annual visits to e-   Organic Search: Traffic from unpaid search on any search engine; Direct: Sessions during which the user typed the name of your website URL into the browser or came to your site via a bookmark; Social: Traffic from any of approximately 400 social networks (not tagged as ads); Referral: Traffic from websites that are not social networks.lactancia.org is lack of scientific information in the lactation section of the brochures and fact sheets prepared by the pharmaceutical industry for its products [26,27].A short phrase very often indicates that the drug is contraindicated during BF (or BF "should be discontinued while taking medication", which completely ignores how complicated it can be to interrupt and resume BF, and disregards the proven benefits of BF for mothers and infants).No evidence for this claim is offered or, at the most, it states that medication can pass to breast milk, or in animals (generally rats), it has been detected in breast milk.Nor do they report the amount excreted or the possible or proven problems for either infants or BF.This biased legal-defensive information [26] in prospectuses has conditioned medical professionals to systematically deny the compatibility of BF with taking any medication despite the paucity of according evidence because few or no reactions observed in infants can be definitively attributed to nursing mothers taking medications [15].
With the advent of the information society, and the rise in and importance attached to BF at the start of in the 1990s, this model of absolute incompatibility between BF and medications, and the work of pioneering specialists like Briggs (Drugs in Pregnancy and Lactation, 1983), Dr. Bennet (Drugs and Human Lactation, 1988) and Dr. Hale (Medications and Mother's Milk, 1992), reached professionals and the general public.The creation of the LactMed website (https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm) in 2003 by Dr. P.O.Anderson contributed to this change [28].
The fact that e-lactancia.org is a free-access Internet database based on scientific and up-to-date data, and one that is easy and intuitive managed, allowed us to quickly obtain accurate information, which explains the very large number of queries.
The number of health professionals concerned about maintaining BF is increasing, and they should have accurate information about the compatibility of medications and BF to advise them in their decision making [26,27].The e-lactancia.orgwebsite offers a clear advantage: as it is a digital tool, it allows rapid information dissemination and data can be updated in real time, as highlighted in some articles [29,30].It also helps to avoid the main barrier detected in using online information, especially in the primary healthcare field: lack of time [31].
Although the e-lactancia.orgwebsite is designed to help professionals, the concise style of its comments and its intuitive way of showing the risk level on a traffic light scale have led to mothers themselves being its most frequent users for years, who account for almost two thirds of visits.The e-lactancia.orgwebsite allows BF mothers' active participation in clinical decisions that can affect BF, which can end in the decision to abandon it [30,32], and limit mothers'  perception that the medication, if necessary, can be harmful during BF [33].
Conversely in most countries, the usual ratio between the number of mothers and that of professionals rarely exceeds 10 doctors and 10 nurses per thousand inhabitants [34]; that is, less than 2% on the whole, and 32 % of users are health professionals.These proportions indicate the trust and usefulness that physicians, nurses, midwives, pharmacists and other health professionals place in e-lactancia.org.
The fact that Spanish-speaking countries are the source of most visits and Spanish is the most widely used language for access devices are explained by the origin of the site's creation.Nevertheless, it has reached other countries, such as the United States and Russia, and is accessed in languages like English, Portuguese and Russian [35].
Despite e-lactancia.orgnot having as an application (app) intended for tablets or smartphones, the responsive or adaptive web design of elactancia.orgsince 2013 has led to most accesses occurring via mobile phones rather than personal computers and tablets, which falls in line with Internet users' current trends [35].
In 5 years, 63.8 million entries to the e-lactancia.orgwebsite were counted, of which slightly less than half (30.6 million) were product visits (medications, plants, diseases, others) because most users enter elactancia.orgthrough the landing page to search for a desired product.There are also several pages on e-lactancia.orgthat are not productrelated, like a page to make donations, a page for sponsors, a page for endorsements, the "About us" page and a page for statistics, which users also visit.
The most searched products on the e-lactancia.orgtool reflect, among professionals, both the most prescribed and those that suggest doubts about compatibility with BF.Among mothers, the most consumed are those related to their concerns about the compatibility of their use during lactation [16].These patterns are distributed similarly to that indicated in other studies [14].
As adequate accessible information is lacking, professionals often recommend mothers interrupting BF [13,16], although few products are absolutely contraindicated [15,32,36].Hence it would be appropriate to make a risk assessment and search before making a decision [13,37].
The most searched groups of drugs were antibacterial and nonsteroidal anti-inflammatory drugs (NSAIDs), with more than 3.7 million visits each, followed by analgesics and antihistamines (1.7 million views each).However, when we added systemic and topical phytotherapy products together, phytotherapy was the most searched product group, with 4.8 million visits in all, which reflects the high level of approval of these products by nursing mothers and some professionals [38].The authors of e-lactancia.orgemphasise that bibliographic references on phytotherapy products and lactation are often missing, which would make an adequate risk assessment difficult.
Of the 1866 products referenced in e-lactancia.org,only 75 account for 50 % of total visits, with ibuprofen at the top (1.9 million visits), followed in this order by: paracetamol, amoxicillin, loratadine and diclofenac (with more than half a million visits each).It is noteworthy that the sixth most searched product is alcohol, which reflects mothers' concern about the effects that alcohol consumption may have on BF or their infant.In addition to discouraging it, it is advisable to well report the waiting times for BF and to avoid co-sleeping after drinking because approximately half western BF mothers consume alcohol during BF [39].Of these 75 most visited products, only two, star anise and cocaine, are classified on e-lactancia.orgas a very high risk, six are classified as high risk, and the remainder as low or very low risk.
On 30 June, 2015, the Food and Drug Administration (FDA) of the United States published new recommendations on the labelling of drugs and products: the Pregnancy and Lactation Labeling Rule (PLLR) [30,40].This forced a change in the subsection entitled "Nursing Mothers" to "Lactation", which should be divided into three sections: Risk Summary, a summary of drug absorption; concentration in milk; the actual or estimated daily dose for infants; the effect of the drug on milk production; a risk/benefit statement; Clinical considerations, which describes recommendations about how to minimise exposure to a drug and how to control undesirable side effects; Data Section, which should include all the available studies supporting the summary of risk assessments.In addition, whenever there data are available for humans, no animal data should be included [30,40].e-lactancia.orgcomplies with these FDA requirements, which have gradually been implemented until 2020.Furthermore, e-lactancia.orgincludes the following: product name, synonyms, chemical formula; the Anatomical, Therapeutic, Chemical Classification System (ATC); date of the last update of the last searched product or medication; if there has been any change in the risk level; a comment with data on absorption and excretion in breast milk; estimated dose for infants; possible effects on infants or lactation; assigning the risk level on a colour-coded scale (green: very low risk; amber: low risk; orange: high risk; red: very high risk); possible safer alternatives, as shown in Fig. 2; pharmacokinetics data; the list of references consulted to make recommendations (none of these should be accompanied by animal data); finally, a list of trademarks.

Conclusion
The number of users and consultations in e-lactation significantly increased during the study period.Mothers and fathers were the main website users, followed by health professionals.The main consulted high (orange), 3: very high (red).
groups were antibacterial agents, NSAIDs and systemic phytotherapy.
The main consulted products that sttod out were ibuprofen, paracetamol and amoxicillin.These results are very interesting because they reveal an increased use of this web resource, and probably other similar ones, to solve doubts about the compatibility of drugs and other substances with BF.In addition, determining the main consulted groups and products opens up work lines in order to, for example, improve health professionals' education and to attract those parents interested in BF.Future research about how users (parents and health professionals) interact with this information should be conducted.

Summary table
• We provide relevant data about visits, user profiles and most visited products on the www.e-lactancia.orgwebsite • We observed how this website was increasingly accepted given its compatibility with breastfeeding • The increased visits by health professionals was noteworthy and in accordance with technological evolution as websites can now be accessed with mobile phones • It has been shown as a tool for determining the compatibility of many products with breastfeeding, it is scientifically endorsed and it complies with Food and Drug Administration recommendations

Fig. 2 .
Fig. 2. Example of the data shown when consulting a product at www.e-lactancia.org.

Table 1
Numbers of users, sessions and pages and average pages per session visited by users of e-lactancia.orgduring the study period (2014-2018).

Table 2
Access channels to e-lactancia.orgused by users during 2014-2018.Number and percentage of total annual access and total.

Table 5a
Most visited products, 2014-2018 (5 years), number of searches and percentage of all (30,623,967) the product searches.Level of risk assigned in e-lactancia.

Table 5b
Most visited products, 2014-2018 (5 years).Number of visits and percentage of the total.