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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)
Access to HIV / AIDS drugs and diagnostics of acceptable quality. Procurement Quality and Sourcing project. Manufacturers and suppliers whose HIV-related medicines have been found acceptable, in principle, for procurement by UN agencies. 18th ed.
Geneva, Switzerland, WHO, 2004 Aug 9. 19 p.A "Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality" was actively started by WHO in collaboration with other United Nations Organizations (UNAIDS, UNICEF, and UNFPA) in March 2001. The World Bank supports this initiative. The background to the project is described in the project description. The procedure for assessing the acceptability in principle of HIV/AIDS drugs comprises various components including 1) The evaluation of product data and information provided by manufacturers and suppliers, and 2) Inspection of manufacturing sites. Due to the particular properties of several substances used in some pharmaceutical finished dosage forms in the treatment of HIV/AIDS (e.g. chiral activity, isomerism, sensitivity to relative humidity etc.), and the current status where there are no Pharmacopoeia monographs and standards available for several substances and finished products, WHO appointed experts have performed a comprehensive and rigorous evaluation of the products included in the list, with a view to establishing their compliance with international standards. (excerpt)
Journal of the National Cancer Institute. 2004 Jul 7; 96(13):985.A politically challenged debate about labeling condoms with warnings about the link between human papillomavirus (HPV) and cervical cancer has erupted following a related Congressional hearing on the issue in March. Although the dispute centers on the protection of women from cervical cancer, the debate is just as much about ideology: premarital abstinence or monogamy in marriage versus condom use for those who choose to be sexually active. The hearings, called by Rep. Mark Souder (R-lnd.) at the urging of Tom Coburn, M.D., co-chair of the Presidential Advisory Committee on HIV/AIDS continue to raise questions about a public law Coburn authored in 2000 and that former President Bill Clinton signed days before leaving office. Souder confronted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention with his belief that the agencies had not complied with the public law. (excerpt)
In: Westinghouse Population Center. Survey of global patterns of contraceptive distribution in the private sector in selected developing countries, pt. 1. Columbia, Maryland, Westinghouse, 1972. (Contract CSD 3319) p. 107-161This is an analysis of the family planning and contraceptive supply situation in Jamaica. A general treatment of the socioeconomic background of the country precedes the discussion. The governmental health care program and family planning services, as well as services offered in the private sector, are described. Legal requirements and regulations regarding contraceptive import, manufacture, advertising, export, and distribution are described. Companies, contraceptive cycles, and pricing costs involved are tabulated. Private and commercial sector distribution of contraceptives supplement the governmentally-sponsored program. Commercial market potential is assessed. All data is tabulated. During the year 1971, almost 20% of the nearly 300,000 potential customers used some contraceptive product. Almost 60% of them were supplied by public sector agencies; the rest purchased contraceptives through the private sector. Pills, condoms, spermicides, and injections are used in that order of importance.
Trip report: Honduras Contraceptive Social Marketing Program, Tegucigalpa, Honduras, June 11 - June 18, 1984.
Washington, D.C., Futures Group, International Contraceptive Social Marketing Progam, 1984. 25 p. (Project No. AID/DSPE-CA-0087)At the request of the International Contraceptive Social Marketing Project, Tennyson Levy of the Tritora Corporation visited Honduras in June, 1984, to assist the Honduras Contraceptive Social Marketing Project to conduct market research to assess the impact of a 5-week advertising program. The campaign was undertaken to launch the introduction of the program's 1st product, Perla, a standard dose oral contraceptive (OC). During the visit the consultant was asked to assist in the development of an advertising plan for all 4 products which will be distributed by the program. The other 3 products are 1) Prebien, a low dose OC; 2) Guardian, a condom; and 3) Sana, a vaginal tablet. The consultant also helped develop research to guide the development of appropriate packages for the Guardian and Sana products. The distribution of Perla began in March, 1984, and the media campaign was conducted during May, 1984. Monthly sales for March amounted to 5271 cycles, and for May, 11,256 cycles. The campaign consisted of 2 45-second radio spots which ran 30 times a day for a month and a press ad. A visit to 12 pharmacies in June to obtain feedback about the advertising campaign led to the conclusion that the campaign increased awareness of Perla, of how it could be obtained, and of how much it cost; however, the campaign did little to alter women's fears and misconceptions about OCs. Recommendations were made for conducting a 2-phase advertising campaign to further promote Perla. The 1st phase will begin immediately and run for 8 weeks. The objective of the 1st phase will be to address women's fears and misconceptions about OCs. The 2nd phase will run from September 1984-July 1985, and the objectives of this phase will be to promote Perla as a method to avoid pregnancies which might keep women from attaining their personal goals, to encourage married women to use Perla to space their births and to limit family size, and to protect unmarried women from the fear of an unwanted pregnancy. Specific messages and channels for disseminating the messages for each phase of the campaign were specified. Communication strategies for the other 3 products were also provided. Guardian messages will seek to equate the macho image with responsible behavior. The Prebien campaign will be directed toward 16-24 year olds, and the Sana compaign will stress that vaginal tablets are a convenient method for lactating women, for teenagers, and for women who engage in sexual activities infrequently. A research strategy for conducting market research throughout the 13-month advertising campaign was developed. A previously developed survey questionnaire for evaluating the advertising campaign was redrafted, and an appropriate sampling strategy for the survey was developed. Pertinent research topics were identified, and a research time table was proposed. An advertising budget was also developed. Funds currently available for the campaign (US$93,000) are inadequate, and additional funds must be requested. The radio spots used in the initial Perla campaign are included in the appendix.
In: Infant and child survival technologies, annual technical update No. 1 by Technologies for Primary Health Care Projects [PRITECH]. Arlington, Virginia, Management Sciences for Health, PRITECH Project, 1984 Sep. 15-8.WHO and UNICEF have recommended a universal oral rehydration solution (ORS) for the treatment of dehydration caused by diarrhea. Several features of this formula have been debated. Some pediatricians in developed countries have expressed concern about the sodium content of the solution, arguing that this can potentially cause an excess of sodium in the blood. However, when used properly, significant adverse consequences of the high sodium concentration (90 mmol/liter pf the solution) have not been demonstrated, and formulas employing lower sodium concentrations have not proven uniformly adequate in correcting dehydration. The replacement of glucose with sucrose in ORS has also been investigated. In the past few years, futher studies have been undertaken to investigate possible improvements in the ORS formula. For instance, a formula employing sodium citrate in the same molarity as the sodium bicarbonate has been proven effective in field studies sponsored worldwide by WHO. The citrate is now recommended for all packets as it extends shelf life. Other alternatives and supplements to the simple sugar in the formula are also under investigation. Solutions using rice-based starches have been demonstrated to be as effective in correcting dehydration as those using glucose or sucrose. In addition, the caloric intake is twice as high with rice-fortified ORS as with regular ORS. Research is under way to identify a super ORS in which the formula is modified to increase further the absorption of water and sodium from the intestinal lumen. Controversy over the potable quality of water for preparation of ORS continues. There is no evidence that bacterial contamination in any way changes the physiologic effectiveness of the resulting ORS solution. Recent studies show that boiling ORS does not change its compostion. Thus, to ensure the quality of water ORS can be boiled. More attractive ORS market presentations, e.g., ORS in tablet form, the provision of pre-mixed solutions in cheap containers such as those for juices, are being introduced in the commercial sectors of many countries. Uses of oral rehydration are reviewed for neonates, for hypernatremia and hyponatremia and other dehydrating conditions such as respiratory illness and dengue hemorrhagic fever and shock syndrome.
Contraceptive Technology Update. 1985 Jul; 6(7):93-6.The Today contraceptive sponge is the leading over-the-counter contraceptive for women after 2 years on the market, despite continuing questions about its efficacy and suspected link to toxic shock syndrome (TSS). About 1.5 million women use the sponge and more than 35 million sponges have been sold since the method was approved by the US Food and Drug Administration in 1983. The sponge, made of polyurethane and containing 1 gm of nonoxynol-9 spermicide, has 3 contraceptive features: spermicide release, formation of a barrier over the cervix, and absorption of vaginal secretions and semen. Among concerns that have arisen in the sponge's 2nd year are results of US trials comparing the sponge and diaphragm which showed pregnancy rates for parous users that were twice as high as those of nulliparous users; an in vitro study which concluded that growth and toxin production of TSS-associated staphylococcus aureus is limited in sponge users; changes in the package insert to highlight efficacy data and warnings; and an increase of about 25% in the price of the sponge. The sponge's package insert claims that the life table pregnancy rates among women using the sponge correctly and consistently decline from 8.9-10.7% in the 1st year to 3.4% in the 2nd year. US trials involved about 200 parous women, while worldwide trials including over 800 parous women showed no differences in effectiveness rates by parity. Defenders of the sponge argue that in the US, motivational factors involve age and marital status as well as parity. Some researchers have suggested that parous women may need a larger sponge, possibly because of weaker vaginal muscle tone, but the manufacturer, VLI Corporation, will probably not change the size of the sponge. Recent comparisons of diaphragms and cervical caps, both fitted methods, have also shown a statistically greater pregancy rate among parous women. Laboratory analyses conducted by VLI Corportation's department of research and development showed that the sponge inhibited growth and toxin production of 7 toxigenic strains of S. aureus under all experimental conditions. Researchers believed the citrate buffering system and the nonoxynol-9 in the sponge caused the antibacterial activity. A spokesman for the Centers for Disease Control however stated that 20 definite and 10-15 probable cases of TSS in sponge users have been recorded since 1983. A CDC spokesman said that the chances of getting TSS were about 1 in 1 million for sponge users, but advised that women not use the sponge during menstruation, postpartum, or if there is a history of TSS. The sponge should be completely removed within 30 hours, with medical assistance if necessary. Users should be aware of TSS warning signs.
Kuala Lumpur, Malaysia, SIM, 1973. 18 p.The Malaysian Standard, published under the authority of the Standards Council in May 1973, prescribes requirements and methods of testing rubber condoms to be used as contraceptives for single use. Condoms, which must include teats and rolled rims, are to be no less than 160 mm long excluding the teat and 175 mm including the teat. Width of a conventional parallel sided condom when laid flat must be at least 44 mm and no more than 56 mm. The width of profile of condoms having bulbous profiles when laid flat should be between 44-70 mm except for the region of the closed end. The remaining length should be between 44-56 mm. Maximum weight should be 240 g per gross. Condoms should be of good quality rubber latex and should be transparent or translucent prior to application of dressing material, which must not contain harmful or toxic ingredients or oil and petroleum based grease. After specified tests, condoms should show no signs of leakage of water, should not burst, and should show no visual defects likely to affect serviceability after inflation with air to a diameter of 12.5 cm. Each condom is to be packed in polythene-lined, aluminum or other metal and air sealed, after which it is to be packed in paper, wooden, or other suitable container. Condoms are to be packaged for protection during storage and stored in a cool place no longer than necessary. They should be protected from mechanical damage and from contact with petroleum based grease and related organic products which are extremely harmful to rubber. Each packet is to be marked with the name or trademark of the manufacturer or supplier; expiration date; the words "for single use only" in capital letters; and a warning to protect against heat, direct sun rays, and mechanical damage. The product may be marked with the Standards Institution of Malaysia Certification Mark if the condoms conform to the requirements of the standard. Representative samples are to be obtained to carry out tests specified in appendices to this document, for determination of freedom from holes and bursting strength before and after aging.
Contraception. 1982 May; 25(5):447-56.Silastic implants containing the progestin, levonorgestrel, were placed under the skin of the anterior forearm and tested as a longterm contraceptive system in 101 women. During 5 full years of use, no pregnancies occurred. The 5-year continuation rate was 54%. Menstrual irregularities were the most frequent reason for removal during the 1st year when they caused more than 1/2 the terminations. Some of the subjects elected to continue use of the implants beyond 5 years, allowing release rate data to be obtained through 6 years. From the 2nd through 6th year of use, the implants delivered a constant 30 mcg/day of levonorgestrel to the subjects and even after 6 years, 57% of the original steroid content remained in the capsules. Return of fertility following removal was essentially immediate and not related to time of use. Medical reasons for removal were infrequent and no pattern was discernible. (author's modified)
Diarrhoeal mortality in two Bangladeshi villages with and without community-based oral rehydration therapy.
Lancet. 1979 Oct 29; 2(8147):809-12.To combat dehydration from diarrhea in the village of Shamlapur, multiple community-based points were set up by trained volunteers for the distribution of glucose electrolyte (ORS) oral rehydration salt packets. The comparable adjoining village of Bordil with a population of 3888, obtained its supply of ORS from Shamlapur. Surveillance for 2 years showed that although diarrheal attack-rates were equal, consumption of ORS after diarrhea was 80% in Shamlapur and only 38% in Bordil. There were 8 deaths in Shamlapur due to diarrhea and 23 in Bordil, showing an overall case fatality rate of 0.5% and 2.4% respectively, and a diarrheal mortality rate/1000 population of 0.6 and 2.9 respectively. The observation indicated that although it may not be possible to reduce diarrheal attack rates, easy availability of rehydration solution and its early use after village-based training may save lives, particularly those of children. (Authors' modified)
[Unpublished] 1978. 26 p.The 4 marketing variables of product concerns, pricing, distribution and promotion, as well as planning and finance, transition from Westinghouse toNepali management, and areas needing improvement are discussed for a commercial distribution of contraceptives project in Nepal. The selection process for brand names for project pills and condoms indicated the effort expended in adapting the products for Nepali conditions. Packaging opportunities discussed by the consultants include possible need for introduction of the low-dose pill and addition of "piggy-backed" vitamins with the pills. It was recommended that consumer demand be generated for existing distrigution outlets before new outlets and marketing areas are sought, that th bond requirement for dealers stocking the contraceptives be dropped, and that adequate storage space be sought. Serious problems were found in project advertising in both content and media mix; suggestions for improvement included increased local promotion, market research and sampling of products, and production of a promotional movie. 3 organizations were identified which might be capable of absorbing the project after termination of activities by the present contractor.
Front Lines. 1978 Jun 1; 16(10):4-5.The use of an in-place system has reduced the market price of contraceptive supplies (condom and the pill) in India. Clinic-based delivery systems, by contrast, are too expensive and would prevent lower socioeconomic groups in both urban and rural areas from buying contraceptives. A survey commissioned by AID in 1973 led to feasibility studies in Bangladesh and Jamaica. In Bangladesh, for example, market and consumer studies showed consumers were willing to pay less than 3] for 3 condoms and about 5] for a cycle of birth control pills. An advertising campaign using all media was started and by the end of the first year some 20,000 outlets carried the contraceptive products selling them at one-third the cost of clinic-based delivery systems. Interest in the "social marketing" concept is gaining momentum, and other developing countries are now launching their own programs.
Washington, D.C., American Public Health Association, 1977. 75 p. (APHA Assign. No. 1100-079)In order to evaluate and assess basic progress and problems in the implementation of the AID contract with Syntex Laboratories for a Commercial Retail Sales(CRS) project in Tunisia, various specific tasks and the overtly specific schedules are divided into 6 broad categories: 1) the dissemination of better medical information on oral contraceptives and condoms; 2) publicizing of the products directly to consumers by advertising through mass media, point of purchase, and other advertising promotional methods; 3) improvement of the current commercial system of distributing oral contraceptives and condoms through pharmacies; 4) extension of availability of both products nationwide by initiating distribution through general retail outlets; 5) establishment of a retail sale price affordable by the poor and with sufficient profit incentive for all merchants along the distribution chain; and 6) attainment of an economically self-sustaining system. It is believed that too much emphasis is put on developing a comprehensive, activity-specific plan with a rigid, artificial schedule, and that it is more productive to focus on practical expectations for the program within the general areas of program action. This review of progress to date is therefore centered on actual achievements and obstacles within the 6 program areas than on the detailed requirements and deadlines in both the contract and the marketing plan. Recommendations are made in the following areas: 1) general and basic; 2) administrative; 3) programmatic--information and advertising; 4) programmatic--distribution; and 5) programmatic--pricing. The following appendices are included: 1) evaluation of Tunisian Program, July 1975; 2) GOT documents announcing decisions to restrict importation of oral contraceptives to 3 brands, July 1977; 3) letter exchange between GOT and USAID approving contract AID/pha-C-1143; 4) letters of John Thomas and Robert Smith, 1977; 5) initial package designs for project commodities; 6) report from Institute Superior de Gestion on brand name choices; 7) proposed Advisory Board; 8) examples of information/ education materials produced by ONPEP; 9) list of persons contacted during Nov. 5-14 visit to Tunisia; 10) program statistics, 1971-76; and 11) scope of work for evaluation of CRS project in Tunisia.
Washington, D.C. American Public Health Association, 1975. 16 p. (APHA Assgn. No. 1100-020)A commercial contraceptive distribution program in Bangladesh, funded by USAID and contracted by Population Services International (PSI) was evaluated upon completion of the market testing phase of the operation. The evaluation team reported that the program was generally in compliance with the contract, made a number of recommendations for modifying both the program and the contractual agreement, and offered suggestions for USAID drafting of similar contracts in the future. The evaluation team recommended that the prices should not be so high as to reduce sales but high enough to permit future price setting flexibility, to inhibit smuggling, to enhance the identification of the product as a quality item, to discourage the use of the product for other purposes, and to insure the self-reliance of the program in the future. All pills should be packaged as soon as possible to insure sanitary handling. A timetable for covering the distribution network should be submitted promptly so that distribution and promotional efforts can be coordinated. Expanding the program by adding new administrative units each month was considered an inappropriate approach in a small country. Instead efforts should be made to promote national coverage within 1 year. No decision should be made at this time on whether or not a non-profit organization should be established for carrying on the program after PSI phases out. Additional funds should be allocated for market research and for promotional activities and allocations for consumer attitudinal surveys should be reduced. A foreign advisor shoud be hired to help coordinate the distribution phase since it is difficult to hire a qualified local person given governmental salary restrictions. In reference to the establishment of contract guidelines for future distribution projects in developing countries, the team recommended against the development of a uniform contract. A flexible contract tailored to the needs of the specific country was viewed as more appropriate. The development of a technical marketing plan should not be a contract requirement. USAID should determine the most appropriate form of packaging for the contraceptives and then use this form of packaging in all future distribution programs.
Report prepared during the period April 11 through May 10, 1976, under the auspices of the American Public Health Association, in agreement with the U.S. Agency for International Development. 9 p. (Authorization: AID/pha/C-1100 Ltr. POP/FPS 2/11/76) (APHA Assgn. No.: 1100-031)Summary of observations and recommendations from consultations to assist an Indonesian marketing program and advise on design of a pilot promotion campaign in rural Thailand. The Indonesian program distributed condoms through commercial outlets distributing an indigenous herbal medicine, and was initiated by Yayasan Indonesia Sejaktera (YIS). Sales were lower than anticipated, but there was only modest allocation for promotion. The program met with notable success given the constraints of the existing marketing system, which is almost wholly passive, relying on consumer demand, and the limited staffing and budgetary resources available to YIS. As originally designed the program was too ambitious, and it was recommended that it be continued in a different format. Preconditions that would have to be met included change to an experimental marketing program rather than a commercial distribution project, inclusion of oral contraceptives, and change to an urban setting. Specific recommendations on establishing the project, stimulation of demand, staffing, research backup, feedback mechanisms, pricing, direct selling, repackaging, establishing a brand name, and point of purchase promotion, are offered. The Thai program was at the implementation stage, research on attitudes toward condoms among rural Thai residents and clinic personnel having been completed, and a media promotion designed on the basis of the findings. The consultant met with program personnel and recommended arrangements for implementation. His chief concern was that funds would not be sufficient or not enough time would be allowed to obtain meaningful results.
Studies in Family Planning. April 1976; 7(4):101-108.Social marketing, i.e., the application of commercial marketing techniques to social aims, is 1 means of building family planning into the daily nonclinical structure of rural society in developing countries. An experiment in the social marketing of condoms in rural Kenya was undertaken over a 2 1/2-year period. The pretest market research and a detailed marketing strategy are described. The experimental program proved that condoms can be used to involve rural African males in the process of family planning. The experiment further proved that commercial marketing can provide a nonmedical supplement to established clinical family planning programs. Advertising was found to be necessary to the success of the program with radio and point-of-purchase materials providing the cheapest and most effective coverage. The advertising aspect of the program seems to have increased the level of family planning knowledge and practice among the target population. The success of the program is attributed to the local involvement provided by social marketing. Such a project is amenable to exact evaluation which can prove useful to future programs. It was felt that commercial distribution by mobile van units could be used with other types of contraceptives.
San Francisco, San Francisco Press, 1974. 292 p.Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.
American Journal of Public Health. October 1972; 62(10):1328-1330.A new approach to the task of patient education that recognized the emotional components of human behavior and used appropriate advertising principles was established in a magazine called True to Life. The goal was to design literature aimed at problems of contraceptive continuation rather than problems of initial acceptance; the objective was to help a woman contracept effectively. True to Life contains 6 stories, 3 feature columns, 1 graphic feature, and 2 public service ads. Stories are about characters with whom readers can have healthy identification. Postpartum interviews have indicated that the magazine has been successful.
Family Planning Perspectives. 1983 May-Jun; 15(3):146-8.On April 1, 1983, the US Food and Drug Administration (FDA) approved a disposable vaginal sponge of soft polyurethane foam saturated with 1 gm of nonoxynol-9 as a nonprescription contraceptive offering 2 improvements over products already available: ability to leave in place up to 24 hours, and no need for additional application of spermicide for repeated acts of intercourse. Clinical tests show the sponge to be comparable in effectiveness to other vaginal methods including the diaphragm. Although no major medical complications have been detected in studies of the sponge thus far, concern over the possibility of its causing toxic shock syndrome led the FDA to require package labeling recommending that the product not be used during menstruation. The sponge was developed by the V.L.I. Corporation of California and will be marketed for about $1 under the brand name "Today." The sponge must be moistened with water before insertion to activate the spermicide, and is believed to prevent conception by releasing the spermicide over 24 hours, blocking the cervix to some extent, and absorbing sperm. The sponge has undergone 5 years of clinical testing in the US and abroad and is the 1st nonprescription contraceptive to go through the safety and efficacy tests required for prescription drugs and devices. Controlled, comparative tests conducted by the International Fertility Research Program began in 1979 in volunteers aged 18-40 who were randomly assigned to the sponge or another vaginal method. Available results are based on 1582 sponge users and 1579 controls. The data reviewed by the FDA advisory committee were based on 720 sponge users and a similar number of diaphragm users in the US segment. The 12-month pregnancy rates from the US trials were 15.8/100 women for the sponge and 11.6/100 women with the diaphragm, not a statistically significant difference. The US data suggest that about 4% of users will develop allergic reactions such as itching, irritation, and rash.
Irvine, California, VLI Corporation, Professional Relations Department, 1983 Jun. 9 p.A new vaginal contraceptive sponge (Today) successfully completed the US Food and Drug Administration NEW DRUG review process for safety and efficacy on April 1, 1983. The Today sponge will be marketed as an over-the-counter drug. The product consists of a resilient, hydrophilic, polyurethane foam sponge impregnated during manufacture with nonoxynol-9 (N-9), a spermicide in use worldwide for over 20 years. N-9 has been classified as safe and effective by the FDA Advisory Review Panel on OTC Vaginal Contraceptives. Contraception with the Today sponge occurs by: 1) spermicidal action of N-9, 2) sperm absorption into the sponge, and 3) blockage of the cervix. The principal advantage of the Today contraceptive sponge, aside from being available without prescription, is that it separates the act of contraception from that of intercourse, thus permitting for the 1st time, sexual spontaneity with a vaginal contraceptive. Multiple coital episodes are possible with a single sponge. Preclinical USP toxicity studies, mutagenicity assays, allergenic response tests, microbiological studies, and human clinical trials conclusively show no evidence of a significant health risk. The product was found in laboratory tests to be hostile to the growth of Staphylococcus aureas, suspected in the etiology of Toxic Shock Syndrome (TSS). Clinical trials with the Today contraceptive sponge, however, were not large enough to assess the risk of developing TSS. Particular attention has been directed to demonstrating safety with respect to carcinogenicity and mutagenicity. Assays for monomers have continually shown the finished product sponge and the polymeric sponge alone to lack any concerns in this area. These assays are conducted on a continuing basis through a formal stability program now in its 3rd year. This stability program includes accelerated testing at both high and low temperatures for up to 3 months, which has confirmed a lack of product degradation. Further, and most significantly, the product has been subjected to a stringent series of carcinogenicity and mutagenicity screens consisting of both the Ames Salmonella Mutagenicity Test and the Mouse Lymphoma Forward Mutation Assay. These tests have been conducted by both Huntingdon Research Center and Litton Bionetics, and have been successfully passed by the Today sponge in every instance. Phase I trials beginning in 1977 (100 women) demonstrated general acceptability and led to improvements in contraceptive capability. Phase 2 clinical trials beginning in 1978 (400 women) produced a cumulative 6-month life-table pregnancy rate of 5.98/100 women; the protocol called for 1 month use of a single sponge with reuse/washing permitted for a maximum of 10 washings. Phase 3 randomized comparative trials (1600 women) began in 1979 and are ongoing internationally and in the US. This protocol calls for a single sponge use for up to 48 hours wear time. Data to date indicate that sponge effectiveness is in the same range as other vaginal contraceptives. Analysis of the outcome of pregnancies during and after use of the sponge indicates no teratologic or embryologic effects. Of the 719 women in the US studies, 1.7% discontinued because of itching, irritation, rash; 1.9% discontinued because of allergic reactions. These results are consistent with the normal allergenic reactions experienced with the use of N-9. Since insufficient numbers of women in the Phase 3 studies chose to use the sponge for a full 48 hour period, statistical analysis of effectiveness data permits only a single day use recommendation. Thus, in the US, users are instructed to rely on the sponge for pregnancy prevention no longer than 24 hours and to leave the sponge in place at least 6 hours after the last episode of coitus. (author's modified)
Piact Product News. 1983 Dec; 5(1):4.when a major donor of contraceptives changed the packaging specifications of norethindrone/mestranol oral contraceptives (OCs), the change raised some questions as to product shelf life. The new specifications called for the OCs to be packaged in bulk with 100 blister packs/aluminum/plastic overpack. These revised packaging specifications would lead to removal of the blister pack from the protective overpack at an earlier point in the supply chain, and therefore to earlier potential exposure to high temperatures and humidity. However, stability trials conducted by Kabalikat ng Pamilyang Pilipino in Manila have shown no significant deterioration in norethindrone or mestranol content, content uniformity, tablet hardness, disintegration time or blister pack integrity after blister packs without the protective overpack were exposed for 6 months to high humidity and temperatures as high as 60 degrees Celsius. Stability for longer than 6 months remains speculative and should be tested in actual field conditions. Within the limits of the study, however, these results suggest that OCs remain stable with or without the aluminum overpack. (full text)