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[The consideration and several suggestions on the national standard GB 7544 natural latex rubber condoms--requirements and test methods]
Zhongguo Yi Liao Qi Xie Za Zhi. 2010 Nov; 34(6):448-9.It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products, microorganisms to be controlled and the packaging and label. As a result, the suggestions were put forward.
[Washington, D.C., PSI], 2010 May.  p.FoQus on Traders is a pilot methodology intended to better understand retailers’ decision-making about stocking and selling PSI products. To streamline the distribution and sales of PSI condoms, PSI / Zimbabwe investigated why retailers did not consistently stock Protector Plus condoms. Bottle shops were included in this study, which helped PSI / Zimbabwe shift its sales and distribution emphasis towards wholesalers.
Global Health. 2010 Fall;  p.Improving the health outcomes for the world’s children is a priority in global health. The recent launch of the Decade of Vaccines by the Bill & Melinda Gates Foundation, strongly supported by the WHO Director General, Margaret Chan, in her recent speech to the World Health Assembly, has renewed the world’s attention and commitment to combating vaccine-preventable diseases. It is good news that many countries now have the chance to add new vaccines to their programs, but we need to ensure that the systems tasked with delivering them are able to cope. Innovative solutions exist -- and they have been shown to significantly improve vaccine performance and delivery. Yet, there is work to be done. Without fully adequate or reliable vaccine delivery systems, the backbone of immunization, lifesaving interventions will not reach the very people who need them most. (Excerpt)
Contraception. 2009 Dec; 80(6):495-6.This editorial addresses the issue of increased prices for IUDs over the last several years as demand has grown. It also discusses the problem of web sites offering low prices on IUDs that are not FDA approved.
American Journal of Public Health. 2009 Oct 15; 99(12)We assessed awareness and experience with the NYC Condom via surveys at 7 public events targeting priority condom distribution populations during 2007. Most respondents (76%) were aware of NYC Condoms. Of those that had obtained them, 69% had used them. Most (80%) wanted alternative condoms offered for free: 22% wanted ultra-thin, 18% extra-strength, and 14% larger-size. Six months after the NYC Condom launch, we found high levels of awareness and use. Because many wanted alternative condoms, the Department of Health and Mental Hygiene began distributing the 3 most-requested alternatives.
Journal of Family Planning and Reproductive Health Care. 2009 Oct; 35(4):217-8.This report provides information on EllaOne®, a new, single-dose oral preparation to help prevent pregnancy after unprotected sexual intercourse or when contraception fails. It describes EllaOne and what is new about it, its mode of action, its effectiveness, side effects, menstrual changes, who can take EllaOne, drug interactions, effects on pregnancy, and effects on breastfeeding.
[Research Triangle Park, North Carolina], FHI, .  p. (Research Brief on Hormonal Contraception)Over-the-counter provision of oral contraceptives by pharmacists is a safe, effective, and practical way to distribute this popular contraceptive method in Jamaica, according to research published in the journal Studies in Family Planning.
Longitudinal antiretroviral adherence in HIV+ Ugandan parents and their children initiating HAART in the MTCT-plus family treatment model: role of depression in declining adherence over time.
AIDS and Behavior. 2009 Jun; 13(Suppl 1):S82-S91.The authors conducted a study to assess the effect of family-based treatment on adherence amongst HIV-infected parents and their HIV-infected children attending the Mother-To-Child-Transmission Plus program in Kampala, Uganda. Adherence was assessed using home-based pill counts and self-report. Mean adherence was over 94%. Depression was associated with incomplete adherence on multivariable analysis. Adherence declined over time. Qualitative interviews revealed lack of transportation money, stigma, clinical response to therapy, drug packaging, and cost of therapy may impact adherence. Our results indicate that providing ART to all eligible HIV-infected members in a household is associated with excellent adherence in both parents and children. Adherence to ART among new parents declines over time, even when patients receive treatment at no cost. Depression should be addressed as a potential barrier to adherence. Further study is necessary to assess the long-term impact of this family treatment model on adherence to ART in resource-limited settings.
Arlington, Virginia, JSI, DELIVER, 2009.  p. (USAID Contract No. GPO-I-01-06-00007-00)USAID's Public Health Product Catalog 2010 is a catalog of condoms and contraceptives provided by USAID.
One versus multiple packs for women starting oral contraceptive pills: a comparison of two distribution regimens.
Contraception. 2009 May; 79(5):369-74.BACKGROUND: Despite World Health Organization and International Planned Parenthood Federation recommendations to provide multiple pill cycles to new users, many programs in developing countries still give only one pill cycle to new acceptors. STUDY DESIGN: To compare provision of a single versus multiple packs of pills, new pill users in 20 matched public sector clinics in Jamaica were assigned to one of two pill regimens in which they received either one (then subsequently three) or four pill cycles at method initiation. The primary outcome was the proportion of women who used pills beyond 4 months. RESULTS: Among 655 women, those receiving one cycle of pills at initiation, followed by counseling and a three-pack resupply, were no more likely to be using pills after 4 months than women who received four packs at initiation (odds ratio=1.33; 95% confidence interval=0.88-2.0). In both pill regimen groups, returning late to the clinic for resupply was a problem. However, more women in the 1+3-pack regimen group returned late to study clinics to obtain their fifth cycle of pills than their counterparts in the 4-pack regimen group (53% vs. 28%). CONCLUSION: Our findings support the recommendation that pill users should be given more than one cycle to start, because an extra visit for resupply contributes to clinic and provider costs. Moreover, providing more pill cycles at initiation would decrease the likelihood that women experience a gap in pill use between cycles.
Contraception. 2008 Nov; 78(5):370-6.OBJECTIVE: In November of 2004, the US Food and Drug Administration (FDA) issued a black box warning regarding skeletal health concerns with depot medroxyprogesterone acetate (DMPA) contraception. This FDA labeling change has the potential to impact how this contraceptive is used. Our goal was to assess the impact of the FDA decision on how Florida obstetrician-gynecologists prescribe DMPA. METHODS: A survey was conducted with questions and case scenarios regarding the use of DMPA before and after the black box warning. The survey was sent to all members of the Florida Obstetric and Gynecologic Society. RESULTS: Four hundred twenty-five surveys were mailed and 149 were returned - a 35% return rate. Forty-six percent of physicians surveyed indicated that they place a time limit on DMPA use, and 66% stated that this limit was based on the FDA black box warning. Sixty-five percent of respondents ordered bone mineral density (BMD) testing solely due to the use of DMPA, with 58% indicating that this decision was based on the black box warning. Eight (5.4%) of the respondents indicated they selectively prescribe bisphosphonates for patients based solely on the use of DMPA, while 33% of respondents state that they use estrogen supplementation. There was a trend towards fewer DMPA injections per week after the black box warning as compared to before; however, this trend was not statistically significant (p<.125). CONCLUSION: Respondents may be writing fewer prescriptions for DMPA, are likely to institute a time limit on said prescription and are likely to order BMD testing, using the black box warning as justification. Continued education is necessary to prevent inappropriate restrictions on DMPA use and the performance and/or prescription of inappropriate tests and medications.
AIDS and Behavior. 2008 May; 12(3):452-458.The aim of this article is to examine the impact of the FDA's proposed condom package labeling on HIV-related beliefs about condom effectiveness, on intentions to recommend condoms for friends to use, and intentions to use condoms. Using a nationally representative survey we randomized 1,194 adults ages 18-65 years into one of three condom label conditions: the current label on condom packaging; a label with the proposed FDA language; and a label with CDC language on condom effectiveness. In short, there are no significant differences between the proposed FDA label and the current label on HIV-related beliefs and intentions. In contrast, from an HIV prevention perspective, the CDC condom language appears to offer a better alternative to the current condom label for unmarried populations. (author's)
Bethesda, Maryland, University Research Company, Quality Assurance Project, 2004 Dec. 47 p. (QAP / WHO Field Report)The traditional approach to malaria diagnosis has been examination by microscope of a thick blood smear from the individual suspected of being infected. In an attempt to provide a more rapid alternative, companies worldwide have developed malaria rapid diagnostic tests (RDTs). Although RDTs can be effectively used in clinical settings by trained personnel, their greatest potential use is in rural areas with limited access to health and laboratory facilities. Using RDTs for diagnosis at the community level will shorten the delay between the onset of symptoms and the beginning of appropriate treatment. It will also slow development of resistance and lead to significant cost savings by avoiding unnecessary use of antimalarials. However, achieving a high level of sensitivity and specificity with RDTs in this context will require a product designed, labelled, and explained so that community health workers (CHWs) can use it accurately with minimal formal training and supervision. In partnership with theWHO Regional Office for the Western Pacific, the Quality Assurance Project (QAP) carried out quality-design research in the Philippines and the Lao People's Democratic Republic to develop and test a generic RDT job aid, mainly pictorial, that could be adapted with little modification for use with different RDT products and in different cultural settings by health workers with low literacy skills and with little or no prior training in product use. (author's)
[Unpublished] . 85 p.This guide to formative research on zinc administration during diarrhea was designed to assist a multicenter zinc study coordinated by The International Network of Clinical Epidemiology (INCLEN) between 2002-2004 v , and jointly supported by INCLEN, JHU, USAID and WHO. A zinc intervention and effectiveness trial was carried out in seven sites: (1) Lucknow, India; (2) Nagpur, India; (3) Manila, Philippines; (4) Pretoria, South Africa; (5) Cairo, Egypt; (6) Addis Ababa, Ethiopia; and (7) Fortaleza, Brazil. Prior to the intervention trial, formative research was to take place in each site to facilitate instrument construction, zinc message development in local languages, intervention monitoring, and evaluation. The guide was largely created in the field in the Philippines by a team of three social scientists having considerable research experience on diarrheal disease and pharmaceutical practice. Given the absence of well trained social scientists at most of the trial sites, the guide was developed for use by teams having little expertise in health social science. Researchers at each site were encouraged to review existing social science research on diarrhea and ORT in their locale, and when possible to enlist the assistance of local social scientists in the formative stage of their research. (excerpt)
Training manual. Training providers on packaging nevirapine oral suspension using the nevirapine infant-dose pouch.
Seattle, Washington, PATH, 2006 Aug.  p. (USAID Cooperative Agreement No. GPH-A-00-01-00005-00; USAID Development Experience Clearinghouse DocID / Order No. PN-ADI-174)This training manual was developed to assist programs planning to introduce the nevirapine infant-dose pouch into prevention of mother-to-child transmission of HIV/AIDS (PMTCT) programs. This brief manual is intended for adaptation by programs and can be implemented by itself or integrated into ongoing training. (excerpt)
Sourcing guide. The nevirapine infant-dose pouch for use in prevention of mother-to-child transmission of HIV / AIDS programs. Version 1.
Seattle, Washington, PATH, 2006 Aug. 23 p. (USAID Cooperative Agreement No. GHA-A-00-01-00005-00; USAID Development Experience Clearinghouse DocID / Order No. PN-ADI-175)As part of a public-private partnership with the US Agency for International Development (USAID) and Boehringer Ingelheim (BI; manufacturer of Viramune®1 brand nevirapine), PATH developed a simple solution, the nevirapine (NVP) infant-dose pouch. This pouch can help prevention of mother-to-child transmission of HIV/AIDS (PMTCT) programs overcome the packaging challenges to increased coverage of at-risk newborns with the infant dose of NVP. The purpose of the Sourcing Guide is to provide PMTCT programs with the information they would need to independently procure NVP infant-dose pouches for use in PMTCT services. While PATH developed the NVP infant-dose pouch and validated its use in the field, PATH is not a manufacturer or supplier of the pouch. PATH's design for the pouch uses readily available packaging materials and processes which may be locally available in many countries. This guide will help programs either: Procure pouches from a current manufacturer(s) identified by PATH; or Engage a local or regional packaging manufacturer to produce pouches of similar function and quality. (excerpt)
Contraception Report. 1999 Jan; 9(6): p..For the first time in the United States, emergency contraceptive pills carrying Food and Drug Administration (FDA)-approved labeling are commercially available. The specially-packaged product, the PREVEN Emergency Contraceptive Kit, contains four pills of a high-dose combination of ethinyl estradiol and levonorgestrel oral contraceptives (OCs). The product is for women who have had unprotected sexual intercourse within 72 hours of use who do not want to become pregnant. The high-dose method has been available in some other countries since the 1970s. Globally, the method is known as the Yuzpe regimen, postcoital contraception or the "morning-after pill." The regimen has been marketed in Europe since 1984. While some OCs have been used "off-label" for emergency contraception, routine use has been limited in the US. A survey commissioned by the Henry J. Kaiser Family Foundation of 2,002 US adults found that only 1% said they or their partners had used emergency contraception. A second survey of 307 obstetrician-gynecologists found that although about 70% said they had prescribed emergency contraception within the last year, 77% did so infrequently--five or fewer times. (excerpt)
Revista de Saude Publica / Journal of Public Health. 2006 Jun; 40(3):513-520.The objective was to assess the advances in the Brazilian norm for commercialization of infant foods from 1988 to 2002, comparing the different texts with each other and with the International Code of Marketing of Breast-Milk Substitutes. This was a descriptive study based on data collected from documents, reports, ordinances and resolutions from the Brazilian Ministry of Health. The versions utilized in the comparison were from 1992 and 2002. Comparative analysis made it possible to identify important advances in the legislation. In 1992, liquid and powdered milk were included in the scope, along with teats and dummies (pacifiers), and also warning phrases in advertising and on product labeling. In 2002, regulations for products were published by the National Agency for Sanitary Surveillance, thereby strengthening supervisory actions and including regulations for baby foods, nutrient formulae for high-risk newborns, and nipple protectors. The phrases used in commercial advertising and on product labeling, including dummies, teats and bottles, became Ministry of Health warnings. The labeling was defined according to product types, on the basis of more restrictive rules. Significant modifications in the control over the marketing of products aimed at mothers during the lactation period. However, there are still some legislative questions that would make it possible to improve the Brazilian norm, in order to protect breastfeeding. There is also a need for the government to implement systematic monitoring routines to supervise this legislation. (author's)
Geneva, Switzerland, WHO, 2006.  p. (WHO/FCH/CAH/06.1)This document is updating an earlier document (WHO/CDD/SER/85.8), and provides information on the manufacture of the new ORS that, since 2003, is recommended by WHO and UNICEF. It has been prepared to assist national authorities in establishing the local manufacture of a product of pharmaceutical quality, in order that they may become self-reliant in meeting the needs of their national diarrhoeal diseases control activities. It is emphasized that the methods recommended in the document are meant to serve as guidelines, and that they need to be adapted to meet local requirements and conditions, provided they follow the principles of Good Manufacturing Practices for pharmaceutical products (WHO Technical Report Series, No 908, 2003) that can be found in the annexes of this document. Specific information on "Quality Management", "Personnel", "Validation" and "Qualification" can be found in this annex. (excerpt)
Reproductive Health Matters. 2006 Nov; 14(28):63-67.DKT International is a non-profit social marketing enterprise whose mission is to provide safe, affordable options for family planning and STI/HIV prevention. In Brazil, DKT sells male and female condoms to mostly lower-income couples nationwide. This paper is about the introduction of a ribbed, lubricated, latex condom called Affair to the Brazilian market in 2000. Sales were initially very low, but based on reports that Affair was well liked by some men who have sex with men, we took the opportunity to give Affair that positioning. We worked with our advertising agency, a local research company and Dignidade, a Brazilian NGO working for the rights of men who have sex with men. Two new products - a baggy condom called Affair Sensation and a complimentary lubricating gel called Affair Personal Lubricant - with new packaging and a promotional campaign were launched in February 2006. The billboard advertisement generated controversy in Sao Paulo, where the Advertising Council required it to be taken down due to complaints. However, the controversy helped promotion and at the same time generated public debate on sexuality and human rights. Our overall experience has been positive, sales are up and we have received messages of support for the products and their promotion from consumers. (author's)
Emergency contraception: common legal questions about prescribing, dispensing, repackaging, and advertising.
New York, New York, Center for Reproductive Rights, 2002 Apr. 10 p. (Briefing Paper)In the United States, emergency contraceptive pills (EC) are distributed both "on-label" and "off-label." With respect to "on-label" distribution, two designated EC products-- Preven and Plan B--are currently available and have been approved by the FDA for EC marketing. In addition, some health-care providers continue to provide patients with regular oral contraceptive pills (OCs) for EC use, despite the fact that the OC manufacturers have refused to label their products for postcoital use. This "off-label" use of OCs as EC was long employed before the emergence of designated EC products, and it was given the FDA's explicit "stamp of approval" on February 25, 1997, when the FDA announced that Levlen and Tri-Levlen, manufactured by Berlex Laboratories, and Ovral, Lo/Ovral, Nordette, and Triphasil, manufactured by Wyeth Laboratories, were safe and effective for use in emergency contraceptive regimens. This briefing paper will answer common legal questions about dispensing, repackaging, and advertising oral contraceptives as "off-label" EC. It will also address questions about prescribing, and liability related to the provision of, both "off-label" EC and designated EC products. (author's)
International Quarterly of Community Health Education. 2006; 24(3):215-229.In July 2003, a consortium of three USAID partners launched a project to promote the correct use of color-coded, age-specific, prepackaged drugs (PPDs) to treat malaria promptly in preschool-aged children in Aba, Abia State, Nigeria. A 3-pronged promotional approach included training of patent medicine vendors (PMVs), home visits by community health promoters, and mass media. Five hundred seventy respondents were interviewed in February-March 2004. People heard about the PPDs from medicine sellers (33.4%), health workers (24.3%), the electronic mass media (18.4%), and friends or relatives (13.5%). Most children (81.1%) took Robaquine (chloroquine--CQ), while 108 (18.9%) took Fansidar (sulphadoxine-pyrimethamine--SP). The median amount paid for Robaquine was N50 ($0.36) and for Fansidar, N80 ($0.57). Respondents rated the effectiveness of the PPD treatment as very effective (86.8%). Most respondents had something positive to say about the drug (94.9%) and the packaging (93.8%). Only 19.5%) had a complaint about either the drug or the packaging. Overall, 454 (83.9%) received the correct age-appropriate packet. Continuing education is needed for the PMVs to ensure that they obtain accurate age information about the child and sell the age-specific packet. Underdosing is just as serious a concern as overdosing in Nigeria where parasite resistance is rapidly developing for both drugs. (author's)
Cochrane Database of Systematic Reviews. 2005 Apr 20; (2): p..Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. The objectives were to summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria. We searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS, conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field. Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria. We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information. Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials. A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants). There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations. (author's)
Recommendations for an educational programme to improve consumer knowledge of and attitudes towards nutritional information on food labels.
SAJCN. South African Journal of Clinical Nutrition. 2001 Feb; 14(1):28-35.The needs and objectives of the various groups affected by nutritional labelling illustrate the complex and controversial nature of nutritional labelling and the problems in formulating a simple and easily understood system. Twenty homogeneous white middle-income suburbs were chosen at random from a total of 39 strata. The multistage cluster method of sampling was used to divide each suburb into smaller clusters. One area was chosen at random from each suburb. Twenty homes were then systematically selected to bring the total sample number of respondents to 400. White middle-income women completed a questionnaire analysing consumer attitudes towards and knowledge of nutritional labelling in order to identify the objectives needed for the formulation of an educational programme concerning the nutritional labelling of food containers. The results of the survey suggest that although white middle-income women (N = 388) lacked nutritional labelling knowledge (pass rate < 20%), they had a positive attitude towards nutritional labelling (mean 18.29 ± 4.8). As knowledge scores increased, the following factors became more positive: attitudes towards nutritional labelling (R = 0.2905, P = 0.0000), nutritional education (c2 = 40.9273, P = 0.01), and the use of nutritional labelling in the purchase of food (r = 0.2230, P = 0.0258). The results of this survey suggest a definite need for a nutritional labelling education programme in South Africa. Although the subject group could be considered representative of the top end of the South African market, a comprehensive needs assessment of the relevant target markets that make up South Africa's diverse population should be undertaken for the formulation of a national nutritional education programme. (author's)
Seattle, Washington, PATH, 1998.  p.Emergency Contraceptive Pills (ECPs) must be taken within 3 days after sex. Any of the birth control pills listed below can be used as ECPs. Use only the type of pill your health care provider prescribed for you. Use only one type of pill. One hour before the first ECP dose, take an anti- nausea medicine (like Dramamine II or Benadryl) to reduce the chance of nausea. Repeat according to labeled instructions. This may make you feel tired, so don't drive or drink any alcohol. Take the first ECP dose as soon as convenient within 3 days (72 hours) after unprotected sex (try to time the first dose so that the timing of the second dose will be convenient). Take the second ECP dose 12 hours after the first dose. Important: Do not take any extra ECPs. More pills will not make the treatment work better. More pills will increase your risk of feeling sick to your stomach. (excerpt)