Gender and urban-rural influences on antibiotic purchasing and prescription use in retail drug shops: a one health study.

INTRODUCTION: Few studies have reported antibiotic purchases from retail drug shops in relation to gender in low and middle-income countries (LMICs). Using a One Health approach, we aimed to examine gender dimensions of antibiotic purchases for humans and animals and use of prescriptions in retail drug shops in Bangladesh. METHODS: We conducted customer observations in 20 drug shops in one rural and one urban area. Customer gender, antibiotic purchases, and prescription use were recorded during a four-hour observation (2 sessions of 2 hours) in each shop. We included drug shops selling human medicine (n = 15); animal medicine (n = 3), and shops selling both human and animal medicine (n = 2). RESULTS: Of 582 observations, 31.6% of drug shop customers were women. Women comprised almost half of customers (47.1%) in urban drug shops but only 17.2% of customers in rural drug shops (p < 0.001). Antibiotic purchases were more common in urban than rural shops (21.6% versus 12.2% of all transactions, p = 0.003). Only a quarter (26.0%) of customers who purchased antibiotics used a prescription. Prescription use for antibiotics was more likely among women than men (odds ratio (OR) = 4.04, 95% CI 1.55, 10.55) and more likely among urban compared to rural customers (OR = 4.31 95% CI 1.34, 13.84). After adjusting for urban-rural locality, women remained more likely to use a prescription than men (adjusted OR = 3.38, 95% CI 1.26, 9.09) but this was in part due to antibiotics bought by men for animals without prescription. Customers in drug shops selling animal medicine had the lowest use of prescriptions for antibiotics (4.8% of antibiotic purchases). CONCLUSION: This study found that nearly three-quarters of all antibiotics sold were without prescription, including antibiotics on the list of critically important antimicrobials for human medicine. Men attending drug shops were more likely to purchase antibiotics without a prescription compared to women, while women customers were underrepresented in rural drug shops. Antibiotic stewardship initiatives in the community need to consider gender and urban-rural dimensions of drug shop uptake and prescription use for antibiotics in both human and animal medicine. Such initiatives could strengthen National Action Plans.

Motivating antibiotic stewardship in Bangladesh: identifying audiences and target behaviours using the behaviour change wheel.

BACKGROUND: South Asia is a hotspot for antimicrobial resistance due largely to over-the-counter antibiotic sales for humans and animals and from a lack of policy compliance among healthcare providers. Additionally, there is high population density and high infectious disease burden. This paper describes the development of social and behavioural change communication (SBCC) to increase the appropriate use of antibiotics. METHODS: We used formative research to explore contextual drivers of antibiotic sales, purchase, consumption/use and promotion among four groups: 1) households, 2) drug shop staff, 3) registered physicians and 4) pharmaceutical companies/medical sales representatives. We used formative research findings and an intervention design workshop with stakeholders to select target behaviours, prioritise audiences and develop SBCC messages, in consultation with a creative agency, and through pilots and feedback. The behaviour change wheel was used to summarise findings. RESULTS: Workshop participants identified behaviours considered amenable to change for all four groups. Household members and drug shop staff were prioritised as target audiences, both of which could be reached at drug shops. Among household members, there were two behaviours to change: suboptimal health seeking and ceasing antibiotic courses early. Thus, SBCC target behaviours included: seek registered physician consultations; ask whether the medicine provided is an antibiotic; ask for instructions on use and timing. Among drug shop staff, important antibiotic dispensing practices needed to change. SBCC target behaviours included: asking customers for prescriptions, referring them to registered physicians and increasing customer awareness by instructing that they were receiving antibiotics to take as a full course. CONCLUSIONS: We prioritised drug shops for intervention delivery to all drug shop staff and their customers to improve antibiotic stewardship. Knowledge deficits among these groups were notable and considered amenable to change using a SBCC intervention addressing improved health seeking behaviours, improved health literacy on antibiotic use, and provision of information on policy governing shops. Further intervention refinement should consider using participatory methods and address the impact on profit and livelihoods for drug shop staff for optimal compliance.

What contributes to inappropriate antibiotic dispensing among qualified and unqualified healthcare providers in Bangladesh? A qualitative study.

BACKGROUND: Over-prescribing and inappropriate use of antibiotics contributes to the emergence of antimicrobial resistance (AMR). Few studies in low and middle-income settings have employed qualitative approaches to examine the drivers of antibiotic sale and dispensing across the full range of healthcare providers (HCPs). We aimed to explore understandings of the use and functions of antibiotics; awareness of AMR and perceived patient or customer demand and adherence among HCPs for human and animal medicine in Bangladesh. METHODS: We used an ethnographic approach to conduct face-to-face, in-depth interviews with 46 community HCPs in one urban and one rural area (Gazipur and Mirzapur districts respectively). We purposefully selected participants from four categories of provider in human and veterinary medicine: qualified; semi-qualified; auxiliary and unqualified. Using a grounded theory approach, thematic analysis was conducted using a framework method. RESULTS: Antibiotics were considered a medicine of power that gives quick results and works against almost all diseases, including viruses. The price of antibiotics was equated with power such that expensive antibiotics were considered the most powerful medicines. Antibiotics were also seen as preventative medicines. While some providers were well informed about antibiotic resistance and its causes, others were completely unaware. Many providers mistook antibiotic resistance as the side effects of antibiotics, both in human and animal medicine. Despite varied knowledge, providers showed concern about antibiotic resistance but responsibility for inappropriate antibiotic use was shifted to the patients and clients including owners of livestock and animals. CONCLUSIONS: Misconceptions and misinformation led to a wide range of inappropriate uses of antibiotics across the different categories of human and animal healthcare providers. Low awareness of antibiotic action and antibiotic resistance were apparent among healthcare providers, particularly those with little or no training and those in rural areas. Specific and targeted interventions to address AMR in Bangladesh should include educational messages on the rational use of antibiotics and how they work, targeting all types of healthcare providers. While tailored training for providers may increase understanding of antibiotic action and improve practices, more far-reaching structural changes are required to influence and increase responsibility for optimising antibiotic dispensing among all HCPs.

Effectiveness of a large-scale handwashing promotion intervention on handwashing behaviour in Dhaka, Bangladesh.

OBJECTIVE: The behavioural effect of large-scale handwashing promotion programmes has been infrequently evaluated, and variation in the effect over time has not been described. We assess the effect of a large-scale handwashing promotion programme on handwashing outcomes in a community setting in Dhaka, Bangladesh. METHODS: We analysed data from a cluster-randomised trial that included three arms: vaccine-and-behaviour-change intervention (VBC), vaccine-only (V) and no intervention (Control). Data collectors randomly selected different subsets of households each month during the study period and assessed: (i) temporal variation in availability of soap and water at handwashing place; (ii) the use of water and soap by participants when asked to demonstrate handwashing, and; (iii) handwashing behaviour according to structured observation. We used log-binomial regression analyses to calculate prevalence ratios (PRs) and 95% confidence intervals and compare outcomes by study arms. RESULTS: Data collectors surveyed 9325 households over 28 months. In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297). In the entire study period, availability of water and soap was higher in VBC (43%) than in V (23%) (PR = 1.92; CI = 1.72, 2.15) and Control (28%) (PR = 1.53; CI = 1.38, 1.69) households. There were no differences between study arms with regard to use of soap during handwashing demonstrations. Observed handwashing with soap after toilet use was higher in VBC (17%) than in V (8%) (PR = 1.47, CI = 0.58, 3.75) and Control (2%) (PR = 3.47, CI = 0.48, 23.33) groups. At other possible pathogen transmission events, the prevalence of handwashing with soap was ≤3%. CONCLUSION: VBC households maintained soap and water for handwashing, but the prevalence of observed handwashing was low in all study arms. The results underscore the need to strengthen scalable behaviour change approaches.

OBJECTIF: L'effet sur le comportement des programmes de promotion du lavage des mains à grande échelle a été rarement évalué et aucune variation de cet effet dans le temps n'a été décrite. Nous évaluons les effets d'un programme de promotion du lavage des mains à grande échelle sur les résultats dans un cadre communautaire à Dhaka, au Bangladesh. MÉTHODES: Nous avons analysé les données d'un essai randomisé par grappes comprenant 3 groupes: intervention vaccin-changement de comportement (VBC), vaccin uniquement (V) et aucune intervention (contrôle). Les collecteurs de données ont sélectionné au hasard différents sous-ensembles de ménages chaque mois au cours de la période d'étude et ont évalué: 1) la variation temporelle de la disponibilité de savon et d'eau sur le lieu de lavage des mains, 2) l'utilisation d'eau et de savon par les participants lorsqu'on leur a demandé de faire la démonstration du lavage des mains, 3) le comportement du lavage des mains selon une observation structurée. Nous avons utilisé des analyses de régression log-binomiales pour calculer les ratios de prévalence (PR) et les intervalles de confiance à 95%, ainsi que pour comparer les résultats par groupe d'étude. RÉSULTATS: Les collecteurs de données ont interrogé 9325 ménages au cours de 28 mois. Dans le groupe VBC, il y avait une tendance positive significative sur la disponibilité d'eau et de savon de la ligne de base à 9 mois après le début de l'intervention (p-pour-tendances <0,001) et aucune tendance significative au cours des mois 10 à 28 (p-pour- tendance = 0,297). Sur l'ensemble de la période d'étude, la disponibilité en eau et en savon était plus élevée dans le groupe VBC (43%) que dans le groupe V (23%) (PR = 1,92; IC: 1,72 - 2,15) et dans le groupe contrôle (28%) (PR = 1,53; IC: 1,38 - 1,69). Il n'y avait pas de différence entre les groupes d'étude en ce qui concerne l'utilisation de savon lors de démonstrations de lavage des mains. Le lavage des mains observé avec du savon après l'utilisation des toilettes était plus élevé dans le groupe VBC (17%) que dans le groupe V (8%) (PR = 1,47; IC: 0,58 - 3,75) et dans le groupe témoin (2%) (PR = 3,47, IC: 0,48 - 23,33). Lors d'autres événements possibles de transmission d'agents pathogènes, la fréquence du lavage des mains au savon était ≤ 3%. CONCLUSION: Les ménages du groupe VBC ont maintenu du savon et de l'eau pour se laver les mains, mais la prévalence du lavage des mains observé était faible dans tous les groupes de l'étude. Les résultats soulignent la nécessité de renforcer les approches évolutives de changement de comportement.

Provision versus promotion to develop a handwashing station: the effect on desired handwashing behavior.

BACKGROUND: Diarrhea prevalence increases from around the time that complementary foods are introduced. Improving caregiver's hand hygiene during food preparation could reduce complementary food contamination and enteric pathogen transmission. Washing hands with soap is more common when water and soap are together at a convenient location. We conducted a three-month pilot intervention to evaluate two options for setting up handwashing stations: i) provide a handwashing station, or ii) help the family to make their own from available materials. Additionally, we assessed the feasibility of this intervention to be integrated with a child feeding program. METHODS: We conducted the intervention among two groups; 40 households received a free of cost handwashing station and another 40 households were motivated to place their own soap/soapy-water and water vessel near the food preparation and child feeding area. Community health workers encouraged caregivers to wash hands with soap/soapy-water before food preparation and feeding a child. They either assisted study participants to install the study-provided handwashing station at the recommended place or encouraged caregivers to develop their own. Field researchers assessed placement and composition of handwashing stations and the feasibility of integrating handwashing and nutrition messages. RESULTS: By end of the trial, 39/40 households developed their own handwashing station, comprising a bucket, mug and bar soap/soapy-water of which 60% (6/10) households were observed with a functional and complete handwashing station set. Observed handwashing with soap was detected among 8/10 households from the study-provided handwashing station group and 5/10 among households who had made their own handwashing station. Sixty-seven of the 76 caregivers recalled integrated intervention messages on social and health benefits of infant and young child feeding correctly; and all recalled key handwashing with soap times, before food preparation and feeding a child. CONCLUSION: Encouraging households to develop their own handwashing station with soap and water to place at a food preparation/child feeding location is feasible over the short term. In the absence of large-scale provision of handwashing stations, caregivers can be encouraged to create and use their own. Integrating handwashing with soap into a nutrition intervention was feasible and acceptable and should be considered by policy makers.

Designing a handwashing station for infrastructure-restricted communities in Bangladesh using the integrated behavioural model for water, sanitation and hygiene interventions (IBM-WASH).

BACKGROUND: In Bangladesh diarrhoeal disease and respiratory infections contribute significantly to morbidity and mortality. Handwashing with soap reduces the risk of infection; however, handwashing rates in infrastructure-restricted settings remain low. Handwashing stations--a dedicated, convenient location where both soap and water are available for handwashing--are associated with improved handwashing practices. Our aim was to identify a locally feasible and acceptable handwashing station that enabled frequent handwashing for two subsequent randomized trials testing the health effects of this behaviour. METHODS: We conducted formative research in the form of household trials of improved practices in urban and rural Bangladesh. Seven candidate handwashing technologies were tested by nine to ten households each during two iterative phases. We conducted interviews with participants during an introductory visit and two to five follow up visits over two to six weeks, depending on the phase. We used the Integrated Behavioural Model for Water, Sanitation and Hygiene (IBM-WASH) to guide selection of candidate handwashing stations and data analysis. Factors presented in the IBM-WASH informed thematic coding of interview transcripts and contextualized feasibility and acceptability of specific handwashing station designs. RESULTS: Factors that influenced selection of candidate designs were market availability of low cost, durable materials that were easy to replace or replenish in an infrastructure-restricted and shared environment. Water storage capacity, ease of use and maintenance, and quality of materials determined the acceptability and feasibility of specific handwashing station designs. After examining technology, psychosocial and contextual factors, we selected a handwashing system with two different water storage capacities, each with a tap, stand, basin, soapy water bottle and detergent powder for pilot testing in preparation for the subsequent randomized trials. CONCLUSIONS: A number of contextual, psychosocial and technological factors influence use of handwashing stations at five aggregate levels, from habitual to societal. In interventions that require a handwashing station to facilitate frequent handwashing with soap, elements of the technology, such as capacity, durability and location(s) within the household are key to high feasibility and acceptability. More than one handwashing station per household may be required. IBM-WASH helped guide the research and research in-turn helped validate the framework.

Barriers and facilitators to adherence to national drug policies on antibiotic prescribing and dispensing in Bangladesh.

BACKGROUND: The National Drug Policy in Bangladesh prohibits the sale and distribution of antibiotics without prescription from a registered physician. Compliance with this policy is poor; prescribing antibiotics by unqualified practitioners is common and over-the-counter dispensing widespread. In Bangladesh, unqualified practitioners such as drug shop operators are a major source of healthcare for the poor and disadvantaged. This paper reports on policy awareness among drug shop operators and their customers and identifies current dispensing practices, barriers and facilitators to policy adherence. METHODS: We conducted a qualitative study in rural and urban Bangladesh from June 2019 to August 2020. This included co-design workshops (n = 4) and in-depth interviews (n = 24) with drug shop operators and customers/household members, key informant interviews (n = 12) with key personnel involved in aspects of the antibiotic supply chain including pharmaceutical company representatives, and model drug shop operators; and a group discussion with stakeholders representing key actors in informal market systems namely: representatives from the government, private sector, not-for-profit sector and membership organizations. RESULTS: Barriers to policy compliance among drug shop operators included limited knowledge of government drug policies, or the government-led Bangladesh Pharmacy Model Initiative (BPMI), a national guideline piloted to regulate drug sales. Drug shop operators had no clear knowledge of different antibiotic generations, how and for what diseases antibiotics work contributing to inappropriate antibiotic dispensing. Nonetheless, drug shop operators wanted the right to prescribe antibiotics based on having completed related training. Drug shop customers cited poor healthcare facilities and inadequate numbers of attending physician as a barrier to obtaining prescriptions and they described difficulties differentiating between qualified and unqualified providers. CONCLUSION: Awareness of the National Drug Policy and the BPMI was limited among urban and rural drug shop operators. Poor antibiotic prescribing practice is additionally hampered by a shortage of qualified physicians; cultural and economic barriers to accessing qualified physicians, and poor implementation of regulations. Increasing qualified physician access and increasing training and certification of drug shop operators could improve the alignment of practices with national policy.

The Lived Experiences of Community Health Workers Serving in a Large-Scale Water, Sanitation, and Hygiene Intervention Trial in Rural Bangladesh.

Community health workers (CHWs) are key to implementing community-based health interventions and quality can be enhanced by better understanding their lived experiences. The WASH Benefits, Bangladesh trial engaged 540 female CHWs to promote varying health intervention packages. We report on factors influencing their lived experiences during the trial, to aid future recruitment, training and retention of CHWs. Nine focus groups and 18 in-depth interviews were conducted with CHWs. Focus groups and interviews were transcribed and thematic content analysis performed to summarize the results. All CHWs described experiencing positive working conditions and many benefits both socially and financially; these contributed to their retention and job satisfaction. Their honorarium was commonly applied towards their children's education and invested for income generation. CHWs gained self-confidence as women, to move unaccompanied in the community and speak in public. They earned respect from the community and their family members who helped them manage their family obligations during work and were viewed as a resource for advice on health and social issues. Many participated in family decision-making from which they were previously excluded. Health programs should foster a positive experience among their CHWs to aid the recruitment, retention and development of this important human resource.

Pilot of a Low-Cost Elementary School Handwashing Intervention in Bangladesh: Acceptability, Feasibility, and Potential for Sustainability.

Schoolchildren frequently transmit respiratory and gastrointestinal infections because of dense person-to-person contact in schools. We piloted a low-cost handwashing intervention among elementary schoolchildren in Bangladesh. We trained teachers to lead behavior change communication sessions using flipcharts to encourage students' handwashing before eating, after defecating, and after cleaning school toilets; provided handwashing stations (reservoirs with taps and stool + basin + soapy water solution [mix of 30 gm detergent with 1.5 L water] + pump top bottle with steel holder); and formed hygiene committees for maintenance and covering the recurrent cost of detergent. We evaluated intervention acceptability, feasibility, and potential for sustainability at 1 and 14 months after the intervention. At baseline, of 300 before eating events, no one washed hands with soap, and 99.7% (299) did not wash hands at all as soap was unavailable. Out of 269 after toileting events, 0.7% (2) washed hands with soap, and 88% (237) did not wash hands. After 4 weeks of the intervention, 45% (87/195 before eating events), 83% (155/186 after toileting events), and 100% (15/15 after cleaning toilet events) washed both hands with soapy water as children found it accessible, low cost, and child friendly. After 14 months, 9.4% (55/586 before eating events) and 37% (172/465 after toileting events) washed both hands with soapy water for health benefits. The intervention was acceptable and feasible; it overcame limited access to soap and water and was affordable as schools covered the recurrent costs of detergent. Further research should explore long-term habit adoption and impact on health and attendance.

Formative Research to Design a Child-Friendly Latrine in Bangladesh.

In low- and middle-income countries, most latrines are not accessible to young children. We explored how to modify existing pit latrines to make them child friendly. We conducted four focus group discussions with mothers to explore barriers to child latrine use. We then enrolled 20 households with a child aged 3-7 years old to test six enabling technologies developed based on the identified barriers. Two to three weeks after installing the selected enabling technologies in each household, researchers conducted 19 in-depth interviews with caregivers to explore the technologies' acceptance and feasibility. Common barriers included the discomfort of squatting on a large pan, fear of darkness, and fear of a slippery floor. Of the potential solutions, a ring to stabilize the child while squatting in the latrine was preferred by children and was affordable and available. A wooden board with a smaller hole than the usual pan reduced fears of falling and helped eliminate discomfort but was inconvenient to handle and clean. A transparent fiberglass roof tile was affordable, available, increased visibility, and kept the latrine floor dry. In conclusion, the fiberglass roof tile and stability ring were two affordable and locally available technologies that facilitated latrine use by children aged 3-7 years.

Piloting a Shared Source Water Treatment Intervention among Elementary Schools in Bangladesh.

Hundreds of thousands of children continue to die each year from diarrhea. We piloted a low-cost liquid chlorine point-of-use (POU) water treatment among elementary school children in Bangladesh. We began the 1-month intervention in four schools (two urban and two rural) by introducing POU drinking water hardware and behavior change communication. We trained teachers to deliver sessions encouraging students to drink chlorinated water from their own small plastic bottles to avoid disease transmission. We used cue cards and flip charts as visual aids. We evaluated the acceptability, feasibility, and potential for sustainability after 1 month and after 14 months of the intervention. During 1-month follow-up, among 141 drinking events observed, 141 students (100%) drank chlorinated water. In 93 or 66% of events, students used their own bottles, and in 43 (30%) of the events, they used common cups or hands washed before drinking. During the 14-month follow-up, we observed 732 drinking events. In 653 of 732 events (89%), students drank chlorinated water; in 78 events (11%), they consumed water from untreated drinking water sources. Among those who consumed chlorinated water, 20% (131/653) used their own bottles to drink water, 72% (467/653) used common cups, and 8% (55/653) used both hands to drink water. Most stated that they drank chlorinated water because it is safe, it has health benefits, and treatment reduces germs. Introduction of specific hardware, weekly hygiene sessions, and education materials enabled schools to treat water at POU and students to consume treated water.

Pathways to antibiotics in Bangladesh: A qualitative study investigating how and when households access medicine including antibiotics for humans or animals when they are ill.

BACKGROUND: To understand how to reduce antibiotic use, greater knowledge is needed about the complexities of access in countries with loose regulation or enforcement. This study aimed to explore how households in Bangladesh were accessing antimicrobials for themselves and their domestic animals. METHODS: In-depth interviews were conducted with 48 households in one urban and one rural area. Households were purposively sampled from two lower income strata, prioritising those with under 5-year olds, older adults, household animals and minority groups. Households where someone was currently ill with a suspected infection (13 households) were invited for a follow-up interview. Framework analysis was used to explore access to healthcare and medicines. FINDINGS: People accessed medicines for themselves through five pathways: drugs shops, private clinics, government/charitable hospitals, community/family planning clinics, and specialised/private hospitals. Drug shops provided direct access to medicines for common, less serious and acute illnesses. For persistent or serious illnesses, the healthcare pathway may include contacts with several of these settings, but often relied on medicines provided by drug shops. In the 13 households with an unwell family member, most received at least one course of antibiotics for this illness. Multiple and incomplete dosing were common even when prescribed by a qualified doctor. Antibiotics were identified by their high cost compared to other medicines. Cost was a reported barrier to purchasing full courses of antibiotics. Few households in the urban area kept household animals. In this rural area, government animal health workers provided most care for large household animals (cows), but drug shops were also important. CONCLUSIONS: In Bangladesh, unregulated drug shops provide an essential route to medicines including those prescribed in the formal sector. Wherever licensed suppliers are scarce and expensive, regulations which prohibit this supply risk removing access entirely for many people.

Pathways of antibiotic use in Bangladesh: qualitative protocol for the PAUSE study.

INTRODUCTION: Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consumers. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers.The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation. METHODS AND ANALYSIS: In-depth interviews will be conducted with (1) household members responsible for decision-making about illness and antibiotic use for family and livestock; (2) qualified and unqualified private and government healthcare providers in human and animal medicine and (3) stakeholders and policy-makers as key informants on the development and implementation of policy around AMR. Participant observation within retail drug shops will also be carried out. Qualitative methods will include a thematic framework analysis.A holistic approach to understanding who makes decisions on the sale and use of antibiotics, and what drives healthcare seeking in Bangladesh will enable identification of routes to behavioural change and the development of effective interventions to reduce the health risks of AMR. ETHICS AND DISSEMINATION: Approval for the study has been obtained from the Institutional Review Board at the International Centre for Diarrhoeal Disease Research, Bangladesh following review by the Research and Ethics Committees (PR-16100) and from Loughborough University (R17-P081). Information about the study will be provided in a participant information letter in Bangla (to be read verbally and given in writing to participants). A written informed consent form in Bangla will be obtained and participants will be informed of their right to withdraw from the study. Dissemination will take place through a 1 day dissemination workshop with key stakeholders in public health and policy, practitioners and scientists in Bangladesh, and through international conference presentations and peer-review publications. Anonymised transcripts of interviews will be made available through open access via institutional data repositories after an embargo period.