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Extended effectiveness of the Etonogestrel-releasing contraceptive implant and the 20 ug Levonorgestrel-releasing intrauterine system for 2 years beyond U.S. Food and Drug Administration Product Labeling.
Global Health: Science and Practice. 2017 Dec; 5(4):534-539.Add to my documents.
Pharmacoepidemiology and Drug Safety. 2017 Jul; 26(7):827-836.OBJECTIVE: The objective of this study was to examine the impact of the Food and Drug Administration's boxed warning on the utilization of depot medroxyprogesterone (DMPA). METHODS: From the IMS Lifelink data (2001-2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90-day DMPA or 30-day CHC between claims. Days' supply (CHC) and 90-day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode length and proportion of episodes >2 years before and after the Food and Drug Administration's November 2004 boxed warning. Stratified analyses by birth cohort were conducted. RESULTS: From 2001 to 2009, 126 528 DMPA and 651 356 CHC episodes were used for segmented regression. For the DMPA cohort, there was an immediate decline in the mean duration (-34.7 days [confidence interval: -45.4 to -24.1]) and episodes >2 years (-1.9% [confidence interval: -2.9% to -1.1%]) after the boxed warning. We did not observe any change in mean duration or episodes >2 years for the CHC cohort. The largest declines in mean duration and proportion >2 years were seen with the oldest women. CONCLUSION: We observed a modest decline in the mean duration and episodes >2 years for DMPA use immediately after the boxed warning not observed among CHC users. In the stratified analysis, we saw declines in the duration of use >2 years in all age groups, except adolescents who continue to use DMPA for longer than 2 years. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
Southern African Journal of HIV Medicine. 2015; 16(1): p.Condoms are one of the cornerstones to any response to the HIV epidemic. However, targeted marketing strategies that make condoms more attractive to people at high risk of infection are often overlooked. The South African National Department of Health has recently purchased more attractive condoms to distribute in higher-education settings free of charge, targeting at-risk youth including young women. The authors applaud this move but note the importance of expanding better branded condoms to young people elsewhere – for example, via youth clinics and in high schools. Exploratory, routine data from Médecins Sans Frontières in Khayelitsha are presented, showing the popularity of alternatives to the government’s ‘Choice’ brand.
Adherence to a flexible extended regimen for oral hormonal contraception provided in blister packaging compared with an adherence-supporting digital tablet dispenser: historical comparison of data from two clinical studies.
International Journal of Women's Health. 2016; 8:351-6.BACKGROUND: The Clyk digital pill dispenser helps ensure correct and consistent administration of a flexible extended regimen of the combined oral contraceptive, ethinylestradiol (EE) 20 mug/drospirenone 3 mg (EE/drospirenone ; YAZ((R)) Flex Flex), guiding users through the intake cycle and 4-day pill break and providing visible and acoustic daily reminders when pill intake is due. A study showed that the audible alarm function of the dispenser could help reduce the number of missed pills, but it lacked an appropriate "non-dispenser" group for a meaningful assessment of the impact of the dispenser on adherence. This study indirectly assessed the overall effect of the digital dispenser on adherence by comparing data from a treatment with standard blister packaging. MATERIALS AND METHODS: One-year adherence data were compared from two similarly designed, Phase III, open-label, randomized trials of EE/drospirenoneFlex. In study 1, women used diary cards to record adherence with EE/drospirenoneFlex dispensed in blister packs (n=640), and in study 2 the dispenser was used with the alarm activated (n=250) or deactivated (n=248) in addition to using diary cards. RESULTS: A mean (+/-SD) of 4.3 (+/-4.24) missed pills over 1 year were recorded in diary cards among women who dispensed their pills from the blister packages (study 1) compared with 1.0 (+/-2.4) recorded by the alarm-activated dispenser (study 2). In study 2, a mean of 1.9 (+/-4.2) missed pills were reported in the diaries over 1 year compared with 4.4 (+/-9.1) from automatic recording by the dispenser (both arms of study 2), indicating underreporting of missed pills in diary cards vs the digital dispenser. Adjusting for this rate of underreporting, an estimated mean of ten pills were missed over 1 year by women using EE/drospirenoneFlex in blister packs, or ten times more than with the digital dispenser with activated acoustic alarm. CONCLUSION: The digital dispenser helps reduce the number of missed pills and increases adherence.
Point-of-sale promotion of breastmilk substitutes and commercially produced complementary foods in Cambodia, Nepal, Senegal and Tanzania.
Maternal and Child Nutrition. 2016 Apr 7; 12(S2):126-139.In order to assess the prevalence of point-of-sale promotions of infant and young child feeding products in Phnom Penh, Cambodia; Kathmandu Valley, Nepal; Dakar Department, Senegal; and Dar es Salaam, Tanzania, approximately 30 retail stores per site, 121 in total, were visited. Promotional activity for breastmilk substitutes (BMS) and commercially produced complementary foods in each site were recorded. Point-of-sale promotion of BMS occurred in approximately one-third of sampled stores in Phnom Penh and Dakar Department but in 3.2% and 6.7% of stores in Kathmandu Valley and Dar es Salaam, respectively. Promotion of commercially produced complementary foods was highly prevalent in Dakar Department with half of stores having at least one promotion, while promotions for these products occurred in 10% or less of stores in the other three sites. While promotion of BMS in stores is legal in Senegal, it is prohibited in Cambodia without prior permission of the Ministry of Health/Ministry of Information and prohibited in both Nepal and Tanzania. Strengthening legislation in Senegal and enforcing regulations in Cambodia could help to prevent such promotion that can negatively affect breastfeeding practices.
Assessment of corporate compliance with guidance and regulations on labels of commercially produced complementary foods sold in Cambodia, Nepal, Senegal and Tanzania.
Maternal and Child Nutrition. 2016 Apr 7; 12(S2):106-125.National legislation and global guidance address labelling of complementary foods to ensure that labels support optimal infant and young child feeding practices. This cross-sectional study assessed the labels of commercially produced complementary foods (CPCF) sold in Phnom Penh (n=70), Cambodia; Kathmandu Valley (n=22), Nepal; Dakar Department (n=84), Senegal; and Dar es Salaam (n=26), Tanzania. Between 3.6% and 30% of products did not provide any age recommendation and 8.6-20.2% of products, from all sites, recommended an age of introduction of <6 months. Few CPCF products provided a daily ration (0.0-8.6%) and 14.5-55.6% of those that did exceeded the daily energy recommendation for complementary foods for a breastfed child from 6 to 8.9 months of age. Only 3.6-27.3% of labels provided accurate and complete messages in the required language encouraging exclusive breastfeeding, and almost none (0.0-2.9%) provided accurate and complete messages regarding the appropriate introduction of complementary foods together with continued breastfeeding. Between 34.3% and 70.2% of CPCF manufacturers also produced breastmilk substitutes and 41.7-78.0% of relevant CPCF products cross-promoted their breastmilk substitutes products. Labelling practices of CPCF included in this study do not fully comply with international guidance on their promotion and selected aspects of national legislation, and there is a need for more detailed normative guidance on certain promotion practices in order to protect and promote optimal infant and young child feeding.
Cross-sectional survey shows that follow-up formula and growing-up milks are labelled similarly to infant formula in four low and middle income countries.
Maternal and Child Nutrition. 2016 Apr 7; 12(S2):91-105.This cross-sectional survey assessed the characteristics of labels of follow-up formula (FUF) and growing-up milk (GUM) compared with infant formula (IF), including cross-promotion practices between FUF/GUM and IF manufactured by the same company, sold in Phnom Penh, Cambodia; Kathmandu Valley, Nepal; Dakar Department, Senegal; and Dar es Salaam, Tanzania. All products were imported. A wide recommended age/age range for introduction was provided by manufacturers across all sites, with products with an age recommendation of 0-6 months being most prevalent in three sites, representing over a third of all products. Various age categories (e.g. 1, 1+ and Stage 1) commonly appeared on labels. A number of descriptive names (e.g. infant formula and milk formula) per category of age of introduction were used with some appearing across more than one category. Images of feeding bottles were found on most labels across all age categories, but prevalence decreased with older age categories. The majority of FUF/GUM manufactured by IF companies across all sites displayed at least one example of cross-promotion with one or more of the company's IF: two-thirds or more contained similar colour schemes/designs and similar brand names; 20-85% had similar slogans/mascots/symbols. A wide and potentially confusing range of ages/categories of introduction and descriptive names were found, and cross-promotion with IF was common on FUF/GUM labels. Global guidance from normative bodies forms the basis of most low and middle income countries policies and should provide specific guidance to prohibit cross-promotion between FUF/GUM and IF, and all three categories should be classified as breastmilk substitutes.
Seattle, Washington, PATH, 2015.  p.This is part of a series of reports discussing the activities, milestones, and outcomes of the Protection Options for Women Product Development Partnership (2011-2015) dedicated to expanding access to the Woman’s Condom. This report focuses on our work shaping and strengthening markets for the Woman’s Condom in South Africa.
Seattle, Washington, PATH, 2015.  p.This is part of a series of reports discussing the activities, milestones, and outcomes of the Protection Options for Women Product Development Partnership (2011-2015) dedicated to expanding access to the Woman’s Condom. This report focuses on our work shaping and strengthening markets for the Woman’s Condom in China.
Considerations in developing lipid-based nutrient supplements for prevention of undernutrition: experience from the International Lipid-Based nutrient supplements (iLiNS) Project.
Maternal and Child Nutrition. 2015 Dec; 11(Suppl 4):31-61.The International Lipid-Based Nutrient Supplements (iLiNS) Project began in 2009 with the goal of contributing to the evidence base regarding the potential of lipid-based nutrient supplements (LNS) to prevent undernutrition in vulnerable populations. The first project objective was the development of acceptable LNS products for infants 6-24 months and for pregnant and lactating women, for use in studies in three countries (Burkina Faso, Ghana and Malawi). This paper shares the rationale for a series of decisions in supplement formulation and design, including those related to ration size, ingredients, nutrient content, safety and quality, and packaging. Most iLiNS supplements have a daily ration size of 20 g and are intended for home fortification of local diets. For infants, this ration size is designed to avoid displacement of breast milk and to allow for dietary diversity including any locally available and accessible nutrient-dense foods. Selection of ingredients depends on acceptability of flavour, micronutrient, anti-nutrient and essential fatty acid contents. The nutrient content of LNS designed to prevent undernutrition reflects the likelihood that in many resource-poor settings, diets of the most nutritionally vulnerable individuals (infants, young children, and pregnant and lactating women) are likely to be deficient in multiple micronutrients and, possibly, in essential fatty acids. During ingredient procurement and LNS production, safety and quality control procedures are required to prevent contamination with toxins or pathogens and to ensure that the product remains stable and palatable over time. Packaging design decisions must include consideration of product protection, stability, convenience and portion control.
Arlington, Virginia, DELIVER, 2014 Jul.  p.This document details two different types of LLIN packaging options -- biodegradable and recyclable -- that can help malaria prevention stakeholders address the challenge presented by the accumulation of LLIN packing waste in communities. It also detailed another option to vastly reduce the amount of material by packaging LLINs in bulk when they will be used in campaigns. All of these options are alternatives to forgoing any special type of packaging. With each option, programs and stakeholders should review the many contextual issues before deciding the best solution for them. Ultimately, any decision that will contribute to a well-managed LLIN packaging waste plan will contribute to an improved malaria prevention program and a reduced risk of contaminating the environment.
The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.
Food and Drug Law Journal. 2013; 68(2):115-35, i.The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.
Contraception. 2014 Jul; 90(1):1-3.In 2013, European authorities’ changes to the label for NorLevo 1.5, an emergency contraceptive pill, are of compelling interest to reproductive health advocates and clinicians. First, they approved a new description of the product’s mechanism of action, and the second is a warning that it may not work for heavier women. Although these changes were approved simultaneously, the evidence base for these two changes differs in substantial ways. The authors of this commentary argue that the publicly-available evidence (in the form of peer-reviewed studies) around the mechanism of action of emergency contraception is sufficient to support this label change, while more evidence is desired to clarify the relationship between efficacy and weight. [excerpt] Copyright © 2014 Elsevier Inc. All rights reserved.
Mother Jones. 2013 Nov 25;  p.The European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective for women who weigh more than 176 pounds and begins to lose effectiveness in women who weigh more than 165 pounds. HRA Pharma, the French manufacturer of the European drug, Norlevo, is changing its packaging information to reflect the weight limits. European pharmaceutical regulators approved the change on November 10, but it has not been previously reported. This development has implications for American women. Some of the most popular emergency contraceptive pills sold over the counter in the United States --including the onepill drugs Plan B One-Step, Next Choice One Dose, and My Way, and a number of generic two-pill emergency contraceptives -- have a dosage and chemical makeup identical to the European drug. Weight data from the Centers for Disease Control and Prevention (CDC) suggests that, at 166 pounds, the average American woman is too heavy to use these pills effectively. (Excerpt)
CMAJ. 2014 Jan 7; 186(1):E21-2.Add to my documents.
CMAJ. 2014 Jan 7; 186(1):E15-6.Add to my documents.
Aligning new interventions with developing country health systems: Target product profiles, presentation, and clinical trial design.
Global Public Health. 2012 Oct; 7(9):931-945.Many new interventions are being created to address health problems of the developing world. However, many developing countries have fragile health systems and find it difficult to accommodate change. Consequently, it is essential that new interventions are well aligned with health systems and their users. Establishing target product profiles (TPPs) is a critical, early step towards tailoring interventions to suit both of these constituencies. Specific analyses can help identify and establish relevant TPP criteria such as optimal formulation, presentation and packaging. Clinical trials for a new intervention should be designed to address both TPP-specific questions and anticipated use of the intervention in target countries. Examples are provided from research on malaria vaccines that are also applicable to other new public health interventions.
Arlington, Virginia, JSI, DELIVER, 2011 Jul.  p. (Lessons Learned)By repackaging the female condoms, DTTU teams now spend less time taking inventory, loss of product has been reduced, and the inventory data are much more accurate.
Seattle, Washington, PATH, 2010 Aug.  p.The study highlighted in this project Optimize report uses a breakeven cost analysis to compare potential prices, wastage rates, and cold chain requirements for various human papillomavirus (HPV) vaccine presentations.
Seattle, Washington, PATH, 2012 Apr.  p. (Technology Solutions for Global Health)Part of the Technology Updates series, this fact sheet describes PATH’s work to address the problem of vaccines freezing during transport by incorporating an inner vaccine box made of phase-change material into vaccine carriers.
AIDS Alert. 2011 Mar; 26(3):33-4.In February of 2011, the Food and Drug Administration (FDA) approved new labeling for the antiretroviral drug atazanavir (Reyataz) to include dosing recommendations for treatment of HIV-1 infection during pregnancy and postpartum period. The major revisions to the package insert are summarized in this report, as well as other minor changes made for consistency.
Obstetrics and Gynecology. 2012 Apr; 119(4):772-779.OBJECTIVES:: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS:: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS:: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION:: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE:: II.
Psychology Research and Behavior Management. 2012; 5:11-8.Among those who are sexually active, condom use is the only method of protection against HIV/AIDS. Poor condom skills may lead to condom use failures, which can lead to risk of exposure. Despite the wide availability of condom use instructional leaflets, it is unclear whether these instructions sufficiently teach condom use skills. Ninety-two male and 113 female undergraduates were randomly assigned to a control condition (read non-condom instructions) or a treatment condition (read condom instructions). Participants completed self-report measures related to condom use and performed a condom demonstration task. Participants who read the condom instructions did not perform significantly better on the demonstration task, F (1, 203) = 2.90, P = 0.09, eta(2) = 0.014. At the item level, those who read the condom instructions better performed two of the seven condom use steps correctly. These data suggest that condom packaging instructions do not effectively teach condom use skills.
Contraception. 2011 Sep; 84(3):212-3.This commentary explains why the Food and Drug Administration (FDA) should remove the black box warning regarding skeletal health on the package labeling for the injectable contraceptive depot medroxyprogesterone acetate (DMPA). It states that by depriving women of long-term use of this safe, effective product, this black box warning hurts the public health. Copyright © 2011 Elsevier Inc. All rights reserved.
[Seattle, Washington], PATH, 2011 Jun.  p.Facilitated by project Optimize and conducted by a multidisciplinary group of partners, these landscape analyses highlight ongoing work related to five priority areas that comprise the vision for immunization supply systems in 2020. The analyses also highlight critical gaps that need to be addressed to achieve the vision. The five priority areas are vaccine and related products, supply system design, environmental impact, information systems, and human resources.