Compliance with the International Code of Marketing of Breast-milk Substitutes: An Observational Study of Pediatricians' Waiting Rooms

Abstract

The importance of breastmilk as a primary preventative intervention is widely known and understood by most healthcare providers. The actions or non-actions that heathcare providers take toward promoting and supporting breastfeeding families make a difference in the success and duration of breastfeeding. Recognizing this relationship, the World Health Organization developed the International Code of Marketing of Breast-milk Substitutes (the Code), which defines best practices in breastfeeding promotion, including physicians' offices. The pediatric practices' waiting rooms are often a family's first experience with pediatric care. The specific aims of this study were to describe (1) Code compliance, (2) the demographic factors affecting the Code compliance, and (3) the amount and type of breastfeeding-supportive materials available in the pediatricians' waiting rooms. An observational cross-sectional design was used to collect data from 163 (82%) of the pediatric practices in Maricopa County, Arizona. None of the 100 waiting rooms that had any materials displayed (61%) was found to be completely Code compliant, with 81 of the offices having formula-promotional materials readily available. Waiting rooms in higher income areas offered more non–Code-compliant materials and gifts. Breastfeeding support information and materials were lacking in all but 18 (18%) offices. A positive relationship (t₉₇=−2.31, p=0.02) occurred between the presence of breastfeeding educational materials and higher income areas. We were able to uncover some practice-related patterns that impact families and potentially undermine breastfeeding success. To move current practices toward breastfeeding-friendly physicians' offices, change is needed.

Introduction

Supporting breastfeeding has been a focus of public health in the United States and globally. The importance of breastmilk as a primary preventative intervention is widely known and understood by most healthcare providers. Although strides have been made in the United States with breastfeeding initiation rates, exclusivity and duration remain low,¹ prompting increased national efforts to define and enact best practices. The recently published The Surgeon General's Call to Action to Support Breastfeeding² provides a roadmap of how to operationalize best practices for supporting breastfeeding families, targeting providers, public health agencies, hospitals, and others who provide services for breastfeeding families. Recommendations include compliance with the World Health Organization (WHO) International Code of Marketing of Breast-milk Substitutes³ (hereafter referred to as the Code), the Baby-Friendly Hospital Initiative, and other specific measurable outcomes.² One key recommendation concerns the role that primary providers play in advertising and distributing formula company products, a violation of the Code.² ^(p.70) The American Academy of Pediatrics has formally echoed this recommendation by advising “pediatricians not to provide formula company gift bags, coupons and industry-authored handouts to the parents of newborns and infants in office and clinic settings.”⁴ The Academy of Breastfeeding Medicine's clinical protocol (#14) advising how to establish breastfeeding-friendly physicians' offices predates these other recommendations, providing details about operationalizing Code compliance and maintaining best practices.⁵ It is a common occurrence in our lactation training program, which educates over 100 healthcare providers each year, to have participants raise issues about the various formula-promotional items they have received from their pediatricians. This possible disconnect between policy and practice was the impetus for this study. It was the purpose of this investigation to determine if pediatricians' waiting rooms complied with Code recommendations.

As a result of unethical marketing practices by infant formula manufacturers and subsequent high infant mortality and malnutrition related to formula misuse, in 1981 the WHO developed the Code.³ In 1994 under the Clinton administration, the United States signed it. The purpose of the Code is “to ensure the safe and adequate nutrition of infants by ensuring the proper use of breast-milk substitutes.”³ ^(p.8) According to a 2011 UNICEF report,⁶ 103 countries have enacted laws, 35 countries have voluntary provisions, and six countries (e.g., the United States, Somalia, and Chad) have no mandated or voluntary provisions related to Code compliance. The lack of substantial legislation and/or regulations in the United States frequently has been attributed to the power of the multibillion dollar formula manufacturing industry.^7–10 However, after reviewing the past 30 years of research, reports, and commentaries on Code compliance, Forsyth⁹ ^(p.189) concluded that failure to implement the Code is not only the result of formula manufacturers' marketing strategies, but also systemic failure at every level of implementation and monitoring from governmental agencies to individual practitioners. He suggested that intervention at all these levels is essential.

It is with these understandings that this study was undertaken to better determine through empirical methods if pediatricians' office waiting rooms complied with the Code. The specific aims of this investigation were (1) to describe the degree of Code compliance, (2) to explore the demographic factors affecting the degree of Code compliance, and (3) to describe the amount and type of breastfeeding-supportive materials available in the pediatricians' waiting rooms.

Materials and Methods

A cross-sectional observation design was used to simulate parent/guardian experiences upon entering a pediatric practice waiting room. The Arizona State University Institution Review Board reviewed study protocols and determined that this study did not involve human subjects, citing Arizona Administrative Code R9-17-101.24 “Public Place,”¹¹ which lists healthcare institutions, waiting rooms, and reception areas as public places.

Maricopa County in Arizona, the fourth largest county in the United States (9,225 square miles), was the study site. It is predominately urban (i.e., Phoenix and suburbs) with some rural areas. Over 60% of the state's population lives within this county (3.9 million people). It is ethnically diverse: white (58.7%), Hispanic (28.5%), American Indian (5.6%), African American (4.6%), and Asian and other (2.5%).¹² Families with children make up 31% of the population, with 12% on public assistance. Arizona has an undetermined number of undocumented persons who have families that seek pediatric services. There are 53,361 live births per year occurring in 21 hospitals, which include one public and one Indian Health Service hospital.¹³ Of the live births, 51.5% receive the services of the Supplemental Nutrition Program for Women, Infants and Children (WIC).¹⁴ The state ever-breastfed rate (83.2%) is considerably higher than the national rate (76.5%); however, the recommended exclusive breastfeeding at 6 months is lower in Arizona (15.0%) than the national rate (16.4%).¹

Sample

Within Maricopa County, there are 200 pediatric practices.¹⁵ Sample selection criteria were general pediatric practices that did not have an Internationally Board Certified Lactation Consultant on staff, which excluded two practices. To ensure that all areas of this large county were sampled, a sampling strategy based on geographic distribution and the number of practices in each zip code was used; at least 80% of the practices in each geographic area were included in the study. The final sample size (n=163) comprised 82% of the practices.

Data collection and measurement

Each practice was assigned an ID code disconnecting identifying details of the practice from the analysis. The research team created the observation tool based on the four articles of the Code that specify the standards of practice for healthcare providers (Table 1).^3,16 The tool was then reviewed by two Internationally Board Certified Lactation Consultants and two PhD researchers who are specialists in this content area. The tool consisted of two sections: demographic information and a Code Checklist. Demographic data collected were the number of pediatricians and pediatric nurse practitioners and a proxy measure for socioeconomic status (SES) of the pediatric practices' clients. The mean family income within each zip code was collected from U.S. Census data,¹⁷ with the understanding that it was an imperfect measure.

Table 1.

Summary of the International Code of Marketing of Breast-milk Substitutes ³ (Articles 4–7) Relevant to Physicians' Offices

Article	Summary
4	Information and education
	• Governments are responsible for ensuring that information provided on infant/toddler feeding is objective and consistent.
	• All written, audio, and visual infant feeding informational and educational materials should discuss the appropriateness and superiority of breastfeeding. Pictures or text idealizing breastmilk substitutes should not be used.
5	The general public and mothers
	• No marketing, promotion, or samples of products should be given to mothers, the general public, or the retail consumer.
	• No distribution of gifts or products that may promote the use of breastmilk substitutes or bottle feeding
6	Healthcare systems
	• No healthcare facility or institution should be used to promote or display products within the scope of this Code.
	• Only health workers and trained community workers should demonstrate feeding with infant formula to caregivers who need to use it, including warnings about improper usage.
7	Health workers
	• Health professionals should encourage and protect breastfeeding.
	• Samples of infant formula or other products within the scope of this Code should only be provided to health professionals at the institutional level for research or evaluation; no samples should be given to caregivers.

The Code Checklist items are detailed in Table 2, along with the relevant Code³ articles.

Table 2.

Variables Included in the Code Compliance Score

Variable	Definition	Code article(s)
No breastfeeding materials	Absence of breastfeeding-supportive information on infant feeding	4.2; 6.1; 7.1
Formula feeding pamphlets	Educational materials regarding formula and/or bottle feeding	4.2; 6.1–6.3; 6.5; 7.1–7.2
Placards by formula company	Presence of formula company placards in waiting room	6.1–6.3; 7.1–7.2
Formula feeding on poster	Posters illustrating formula and/or bottle feeding in waiting room	4.2; 6.1–6.3; 6.5; 7.1–7.2
TV programming compliance	Waiting room television programming is not WHO compliant	4.2; 6.1–6.2; 6.5; 7.1
Non–Code-compliant magazines	Magazines containing formula advertisements	4.2; 6.1–6.2; 6.5; 7.1
Formula in plain sight	Formula or pictures of formula present in (or visible from) waiting room	4.2; 6.1–6.3; 6.5; 7.1
Coupons for baby bottles	Coupons for baby bottles or other infant feeding devices	6.2–6.3
Formula advertisements	Non–WHO compliant advertisements present in waiting room	6.1–6.3; 7.1–7.2
Formula coupons	Presence of formula coupons in waiting room	6.2–6.3
Staff use of equipment with formula company logos	Visible presence of staff use of equipment (e.g., sign-in clipboards or pens from formula manufacturer) with formula company logos	6.1–6.2; 7.1; 7.3
Formula logos displayed	Presence of formula logos in waiting room	6.1–6.3; 7.1–7.2

Article 5 pertains to manufacturers' and distributors' marketing of artificial baby milks to the general public and mothers and is relevant to all compliance score variables. The staff use of equipment with formula company logos variable was difficult to assess in most of the waiting rooms because of limited visibility of staff.

WHO, World Health Organization.

Study protocols were developed, and each member of the research team was trained by the Principal Investigator to enhance consistency in data collection. Waiting room observations were conducted using a standardized rubric and data collection protocol. Data collectors entered each assigned waiting room and conducted a thorough observation, collecting any readily available educational or promotional material in the waiting room. The Code Checklist was completed immediately upon leaving the practice. The presence or absence of each item was recorded. When non–Code-compliant materials were observed, the brand name of the company was recorded.

To reduce possible bias, the data collectors were not aware of any practices included in the study, other than those they observed. The Principal Investigator and the project coordinator were immediately available by phone to all data collectors during data collection. Data collectors were debriefed after observations, and field notes were kept concerning observations not captured on the observation tool. The reliability of the Code Checklist and data collection procedures was established by using inter-rater agreement. Two data collectors conducted independent observations in 10% of the sample. Each geographical collection area had at least one reliability observation conducted. The rate of agreement was 97%.

Data analysis

Data were analyzed using the IBM (Armonk, NY) Statistical Package for the Social Sciences software (version 19).¹⁸ Descriptive statistics were calculated for all variables; missing data were minimal (<1%). The degree of noncompliance was calculated by summing the 12 dichotomous individual Code Checklist items (range, 0–12); a higher score indicated less Code compliance.

To address the second study aim, frequency distributions of the practice size and mean incomes within the practices' zip code were conducted. To further characterize the SES of each practice area, the mean income in each zip code was dichotomized according to the U.S. Census categories¹² into a “high income” group (upper middle and upper SES categories) and a “non–high income” group. The size of pediatricians' practices was categorized into small clinics (one or two physicians), medium clinics (three or four physicians), and large clinics (five or more physicians). To describe the relationship between SES and size of the practice, χ² analysis was used.

The influence of SES on Code compliance in pediatricians' waiting rooms was assessed using two-tailed, independent t tests to comparing the Code compliance scores with the dichotomized SES variable. A priori power analyses determined that a total sample size of 128 was required to detect modest differences for a two-tailed t test (80% power, p=0.05).¹⁹ Two-tailed, χ² analyses were done to compare the not–high income/high income groups with the individual Code Checklist items. Our sample size exceeded the required sample size of 88 to detect modest differences in the two-tailed, χ² test (80% power, p=0.05).¹⁹

Results

Code compliance

The Code compliance score reflects the number of noncompliant items (maximum of 12) in a waiting room at the time of observation (Table 3); 63 (38.9%) of waiting rooms had nothing displayed in their waiting rooms and were not included in this score. Of the 100 (61%) waiting rooms that displayed information and educational materials, Code compliance scores ranged from 1 to 9, with a mean of 2.25 (SD=1.67). Most frequencies of individual Code Checklist items are displayed in Table 4. Of waiting rooms with televisions (n=96; 58.9%), 13 (13.5%) were showing formula-related promotional content, whereas 12 (12.5%) had the televisions turned off. Ninety-one (63.2%) of the 144 waiting rooms with magazines contained articles or advertisements that violated the Code. The variable “staff use of equipment with formula company logos” proved difficult to assess adequately by observing from the waiting room area in 93% (n=153) of the cases. However, we decided to include the presence of this variable in the Code compliance score when observed; it is likely an under-reporting of the actual number. Six formula company brands were observed; 65% were the one major competitor of the brand currently being distributed by the WIC program.

Table 3.

Code Compliance Score (n=100)

Score ^a	n (%)
1	56 (34.4)
2	75 (46.0)
3	14 (8.6)
4	3 (1.8)
≥5	15 (9.8)

Score reflects the number of noncompliant items (maximum of 12) in the waiting rooms at the time of observation; 63 (38.9%) of waiting rooms had nothing displayed and were not included in the Code compliance score.

Table 4.

Frequency Distribution of Waiting Room Educational and Marketing Materials (n=100)

	Materials [n (%)]
Code Checklist variable	Formula-promotional	Breastfeeding-supportive
Educational materials displayed in waiting room	81 (81.0)	18 (18)
Promotional posters	5 (3.1)	4 (2.5)
Formula-promotional materials
Placards by formula manufacturers	9 (5.5)
Formula logos	11 (6.7)
Formula coupons	17 (10.4)
Coupons for bottles or equipment	10 (6.1)
Advertisements in waiting room	24 (14.7)
Formula samples or pictures in plain sight	11 (6.7)
Breastfeeding-supportive materials
General breastfeeding education materials		8 (4.9)
Lactation services information		3 (1.8)
Arizona Breastfeeding Support Hotline number		3 (1.8)
Breast pump rental information		1 (0.6)

There were 67 (38.9%) waiting rooms that had no information or educational materials. Categories are not mutually exclusive; five waiting rooms displayed both formula-promotion and breastfeeding-supportive materials. Several categories were missing values: educational materials, n=1; formula coupons, n=2; and formula/pictures in plain sight, n=3.

Influence of demographics on Code compliance

Mean annual household income for the pediatric practices' zip code areas was $72,040 (SD=$23,728), ranging from $26,289 to $158,672, with 35% (n=57) located in high SES areas. The mean number of pediatricians per practice was 2.79 (SD=2.41); the majority (63%; n=103) did not employ pediatric nurse practitioners (mean=0.58, SD=0.93). Of practices with pediatric nurse practitioners on staff, 72% (n=43) employed two or fewer. Practice size was significantly associated with SES (χ²=2, n=163, p=0.04), with a greater proportion of large-sized clinics residing in high SES areas.

Pediatric offices located in higher SES areas had significantly higher (t_89.64=−1.97, p=0.05) Code compliance scores, indicating less Code compliance. Waiting rooms in these areas also had significantly more non-Code compliance on three of the individual Checklist items: presence of (a) formula company placards, χ²_1,163=4.21, p=0.04; (b) coupons for baby bottles, χ²_1,163=5.75, p=0.02; and (c) posters of formula or bottle feeding, χ²_1,75=5.36, p=0.02.

Breastfeeding-supportive information

Six of the Code Checklist items were breastfeeding supportive (Table 4). Only 18 waiting rooms had any breastfeeding-supportive materials displayed or available for distribution. Five of the 100 waiting rooms displaying infant feeding materials displayed both breastfeeding-supportive and formula-promotional materials. A positive relationship (t₉₇=−2.31, p=0.02) occurred between the presence of breastfeeding educational materials in the waiting room and higher SES. Lower income practice areas were significantly more likely (t₈=2.42, p=0.04) to have the Arizona Breastfeeding Support Hotline phone number displayed.

Discussion

A community-based observational assessment of compliance with the Code was conducted of the pediatricians' waiting rooms in Maricopa County. Unlike previous studies surveying physicians,^20,21 we chose direct and objective observation of pediatricians' waiting rooms, putting ourselves into a position to see what clients see. As a result, the findings are less likely to be biased. Using this methodology, we were able to uncover some practice-related patterns that impact families and potentially undermine breastfeeding success. No offices were found to be completely compliant, with 81 of 100 of the offices having formula-promotional materials readily available. Breastfeeding support information and materials were lacking in all but a few offices. Unexpectedly, offices in higher SES areas offered more non–Code-compliant materials and gifts, raising questions about why this might occur. These findings are discussed in further detail below.

Code compliance

Lack of Code compliance is not unique to pediatricians' offices; it is a common occurrence in most environments where one finds new mothers.^9,22–24 However, mothers most frequently seek infant feeding assistance from their pediatricians.² As pediatricians are a primary source for evidence-based information and advice, that their offices would show lack of compliance to the evidence-based Code is particularly concerning. The tacit endorsement of manufactured infant formula was pervasive in our sample. Although the display of non–Code-compliant magazines might be interpreted as “passive” noncompliance compared with more “active” displays of coupons or posters supporting formula feeding, the Code makes no such distinction. Of course, our study took place in one major metropolitan area, and great regional differences in breastfeeding-supportive practices do occur.^1,14 This is the first direct observational study to assess Code compliance; many more are needed before we have an accurate picture of the nature of non-Code compliance in this country.

The influence of SES on Code compliance

Unexpectedly, the direction of the relationship between SES and noncompliance demonstrated that higher income areas offered clients significantly more information and gifts from formula companies than did offices in lower SES areas. Perhaps this was influenced by the widespread knowledge that WIC offers free formula to lower SES mothers, resulting in less need to persuade lower SES groups. We found that most of the offices with coupons and formula logo items had formula brands not distributed by the local WIC offices, most likely reflecting the marketing strategy of companies not holding the current WIC contract. It is possible that pediatric practices in more affluent areas were more heavily targeted by formula companies.

Higher SES areas had significantly larger pediatric practices, which may have contributed to these differences in compliance as well. In larger practices it is possible that management of the waiting room fell to nonprofessional staff. We made no attempt to determine who in the practice was responsible for determining materials placed in the waiting room. It is possible that the physician(s) were unaware of the Code violations. Choices made about waiting room content could also be related to perceived practice economic issues (e.g., desiring not to alienate any potential “customers” who have strong preferences for formula feeding or the possibility of reducing the amount of other free items/samples received from pharmaceutical companies that produce infant formulas). Although physicians have the ultimate responsibility for what occurs in their practices, all employees of the practice need to be aware of the importance of adhering to the American Academy of Pediatrics recommendations and to be held responsible for maintaining the Code.^25,26 Guidelines for operating a Code-compliant evidence-based practice are available and easily accessible,^5,26,27 raising questions about why they are not implemented more widely. We have begun a discussion about some of these questions, all of which need further dialog and research.

Breastfeeding-supportive materials

Another unexpected finding was the lack of breastfeeding-supportive materials in office waiting rooms. Over one-third of the offices had no educational materials in the waiting room; only five offices provided both breastfeeding and formula materials. Of course, the breastfeeding-supportive educational materials could have been located within the private areas of the practice. There are several sources of free high-quality evidence-based breastfeeding support materials available to pediatricians' offices; the expense of materials should not be cause for the observed lack of materials. Even in offices where no materials were displayed, creating a neutral environment, one could make the case that an opportunity for public education was missed. Reasons for this choice could be many and need further exploration if we are to understand how to move pediatricians and other primary care providers toward more breastfeeding-friendly office practices.

Would it make a difference in the breastfeeding rates (exclusivity and duration) if pediatricians' offices were Code compliant? There are reasons to think that it would. Australian researchers²⁸ recently reported an evaluation of breastfeeding outcomes after instituting the Academy of Breastfeeding Medicine's Breastfeeding-Friendly Physician's Office protocol⁵ in their pediatric practice. They reported increased duration of breastfeeding exclusivity (n=757) across five time points up to and including 6 months. Howard et al.²⁹ randomly assigned new mothers (n=277) into a group that received advertising and gifts from infant formula companies. When compared with a group of women who received only breastfeeding-supportive materials (n=270), the women receiving formula promotions had significantly higher rates of weaning within the first 2 weeks. In addition, women who had uncertain breastfeeding goals were more likely to breastfeed for shorter durations with less exclusivity. In another study using focus groups, mothers reported that formula advertising undermines breastfeeding by suggesting the inevitability of breastfeeding failure, which was potentiated when healthcare providers appeared to promote formula by providing samples.³⁰ Recent efforts to move hospital practices away from distribution of formula manufacturers' promotional gift bags have demonstrated increased breastfeeding rates at 10 weeks.³¹ These findings have been widely replicated.^8,10,32 Taking this body of evidence into consideration, it is reasonable to expect that improving Code compliance in pediatricians' offices would have a positive affect on breastfeeding rates.

Limitations

The limitations of this study stem from the nature of observational research methods and the sample selection. Despite our efforts to ensure consistency in measurement, it is possible that errors in measurement did occur. We were able to evaluate only the public waiting rooms in pediatric practices. It is probable that the amount of both formula-promotional and breastfeeding-supportive materials is under-reported because of collecting materials only from waiting rooms. Also, it is likely that various breastfeeding support materials are kept in the inner offices and distributed to new mothers. Anecdotal reports from new mothers frequently mention these items being handed out during visits and/or visible within the inner offices. The coupons, formula, gift bags, and other promotional materials kept in places other than waiting rooms were unknown.

Additionally, the cross-sectional nature of this study may have influenced the amount and type of formula-promotional materials available in waiting rooms, which are dependent on the deliveries by formula company representatives. Owing to the cross-sectional and observational nature of this study, it was difficult to accurately measure all of the variables included in this study. Two items on the Code Checklist proved to be problematic: television content and staff use of equipment with formula logos. It was only possible to assess the television program playing when the observer was in the waiting room; it is likely that the non-Code compliance was higher than reported. Staff use of equipment with formula company logos was difficult to assess from the waiting room unless it was obviously displayed by the receptionist. Although these were imperfect measurements, we chose to leave this in the analysis because they accurately reflected what anyone in the waiting room would see.

It was not possible to accurately measure the SES of the pediatric offices' clients, so we used a geographical proxy with the understanding that our findings related to SES were tentative. There was no way to appropriately access exact SES information about clients in this type of study.

We chose to conduct this study using pediatrician's offices only; however, many families seek well-baby care from family practice physicians. We made this choice so that our results would reflect the practices of physicians whose chosen specialty area should reflect a deeper knowledge of evidence-based best practices related to infant feeding. It is not possible to know what percentage of families receive well-baby care from pediatric versus family practice physicians. Therefore, our results cannot be generalized to all well-baby care within this geographic area.

Conclusions

The relationship between pediatricians and commercial infant food manufacturers has been discussed in the professional literature for over 30 years; slow gradual changes have occurred.^25,33,34 It is obvious from our findings that non-Code compliance and the lack of visible breastfeeding-supportive materials are the norm. This study was a beginning attempt to understand how widespread noncompliance with the Code is within pediatricians' waiting rooms. If we are to truly realize the health benefits³⁵ and healthcare cost reductions³⁶ inherent in improving breastfeeding exclusivity and duration, we must move away from current practices toward evidence-based breastfeeding-friendly physicians' offices.

Footnotes

Acknowledgments

The authors would like to acknowledge the assistance of Angela Lober-Campbell, Jessica Hernandez, BA, Edith Perez, MPH, Briana Plimpton, BS, Sarah Thomas, MSN, and Lisa Green-Venezuela for their assistance in data collection. The Southwest Clinical Lactation Education Program provided clerical assistance for which we are grateful. We could not have completed this research without this help.

Disclosure Statement

No competing financial interests exist.

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