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An Act (No. 72 of 1987) to prescribe the law in relation to the sale of condoms and related matters and to repeal the Police Offences (Contraceptives) Act 1941 and the Police Offences (Contraceptives) Repeal Act 1976. Date of assent: 27 November 1987. (The Sale of Condoms Act 1987).
INTERNATIONAL DIGEST OF HEALTH LEGISLATION. 1988; 39(2):387.This Act comprises the following Parts: I. Preliminary (Secs. 1-5); II. Sale of condoms (Secs. 6-8); III. Licenses (Secs. 9-22); IV. Advertising (Secs. 23-24); and V. Miscellaneous (Secs. 25-33). 1 of the provisions in Sec. 6 lays down that a person may not sell or supply a condom unless it complies with the standards prescribed by regulations. Details are given in Part IV of the procedures for the monitoring, by the Publications Classification Board, of advertisements relating to condoms. Details are given in Sec. 32 of the matters in respect to which the Governor may make regulations for the implementation of this Act. Such regulations may, inter alia, deal with the labelling, packaging, information provided in or on packages, and storage of condoms, as well as the procedures to be followed, and the action that may be taken, to prevent the sale or supply of condoms that do not comply with the prescribed standards. It is likewise laid down that, with respect to standards for condoms, the regulations may adopt either wholly or in part and with or without modification (either specifically or by reference) any of the standard rules, codes, or specifications of any prescribed authority (defined to mean (a) the Standards Association of Australia; (b) the British Standards Institution; (c) the International Organization for Standardization; and (d) such other body, organization, or Government department or agency as is specified in the regulation. (full text)
[Unpublished] 1981 Sep 12. 8 p.The product line of Bangladesh's successful social marketing program should be expanded to include Panther condoms. Bangladesh's social marketing program was implemented in 1975 by Population Services International, and in 1976 the Project Council was established and given responsibility for developing policies and operational guidelines for the program. The program has 4 regional sales divisions, and each division is headed by an areas sales manager. Project products are sold in about 65,000 retail outlets. Products currently distributed are 1) Raja, a condom; 2) Maya, a standard dose oral contraceptive (OC); 3) Ovacon, a low dose OC; and 4) Joy, a foam tablet. Prior to the introduction of the Raja condom, a number of commercially marketed condom brands were available in the country. These other brands have almost disappeared from the market. In commercial marketing it is widely recognized that when several brands compete for the consumers' attention, total sales increase. Variety sells for a number of reasons. Consumer tastes and needs vary, and this is the reason Baskin and Robbins sells 31 flavors of ice cream. Professional marketers are keenly aware of the need to offer brands that sell for different prices. For example, soap companies offer brands tailored to the income level of all segments of the population in order to capture a broad market for their products. The addition of new products also leads to an increase in product promotion. If there is only 1 product on the market, advertisers run out of things to say about the product. The addition of competing products gives advertisers new things to say about their product. As a result, public exposure to the entire product line is increased. Commercial marketers also recognize the advantages of introducing a premium, or high priced brand. These products lend status to the entire product line. Social marketers must overcome their hesitancy about introducing products which appeal primarily to middle and upper class or urban segments of the population. If elite groups use a product, the popularity of the product will increase in the general population. In summary, commercial marketing guidelines indicate that the introduction of a higher priced condom into the product line of Bangladesh's social marketing program will not only increase total condom sales but will increase sales of the Raja condom. The Panther condom should be introduced as a luxury brand. The current price of a Raja condom is US$0.01, and the price of a Panther condom should set somewhere between Ta.2.50-Ta.3.00. Sales from the Panther condom will reduce the operating deficit of the program. Panther condoms can be produced by Akwell Industries for about the same price that the company now manufactures Raja condoms. Packaging for the product should be developed locally, and the package should be designed to appeal to the middle and upper classes. An initial supply of 3.5 million Panther condoms should be obtained from the US. This purchase and the intial cost of designing an appropriate package and sample promotional material can be covered by the program's current budget.
Standard specifications for rubber contraceptives (condoms). American National Standard ANSI/ASTM D 3492-77.
In: American Society for Testing and Materials [ASTM]. Annual book of ASTM standards. Part 38. Philadelphia, Pennsylvania, ASTM, 1980. 13-6.This document describes the requirements for condoms made of rubber latex intended for single use as specified by the American Society for Testing and Materials (ASTM) in 1977. Condoms must be manufactured from good quality rubber latex; they may be transparent, translucent, opaque, or colored. Condoms must not liberate toxic or otherwise harmful substances. The open end of condoms must end with an integral rim. 10 condoms out of a batch of 144,000 at most must be tested for design, including length, width, thickness, and mass or weight. Length must be from 160 mm to 180 mm +or- 10 depending on smooth or textured surface and on width; width must be from 49 mm to 52 mm +or- 2-3, again depending on type of surface; thickness must be 0.04 mm +or- 0.07-0.09, and maximum weight must be from 1.50 g to 1.95 g depending on smooth or textured surface. 25 condoms out of a batch of 144,000 at most must be tested for tensile properties, including tensile strength and elongation at breaking. Inspection for leakage must follow ISO 2859, General Inspection Level 1 for an acceptable quality level of 0.4%. Each condom must be filled with 300 cu cm of water and inspected for holes. Each condom must be marked with the manufacturer's name and date of manufacture. Every package must have name and address of manufacturer or distributor, and the name of the country of manufacture. Proper packaging should protect condoms for 10 years or more. Condoms should not be kept in storage longer than necessary, and should be stored in a cool place. One retest is possible before final rejection of lots not conforming to design and physical requirements. No retest is permissible for lots not conforming to test for quality assurance (leakage).
[Letter concerning] public health message regarding which contraceptives provide protection against sexually transmitted diseases (STDs) and which do not.
[Unpublished] . 2 p.In 1983, the US Food and Drug Administration (FDA) informed various consumer groups that it now required manufacturers to note on certain contraceptive labels that the product does not protect against sexually transmitted diseases (STDs), including HIV infection. FDA also asked for help in communicating this message to others. The contraceptives include oral contraceptives (OCs), Norplant, Depo-Provera, and IUDs. FDA is in the process of reviewing scientific studies regarding spermicides, Today Sponge, cervical caps, and diaphragms before taking any action on the relabeling of these contraceptives. The modified information must be conspicuously displayed and must be clear, understandable to the consumer, and not overshadowed by other information. FDA has taken this action in an attempt to eliminate the confusion created by the information of previous labels and contraceptive packages concerning STDs and HIV transmission. Various consumer representatives and health professionals had informers FDA that this information confused people who practice risky sexual behavior, especially teenagers and young adults. Since 1987, FDA has recommended that natural-membrane condoms be labeled as inferior to latex condoms in providing protection against STDs. Individual latex condom wrappers and the outer packages not state: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. "The natural-membrane condom packages read: "This product is intended to prevent pregnancy. It does not protect against AIDS and other STDs. In order to help reduce the risk of infection of many STDs, including AIDS, use a latex condom." FDA requires almost identical labeling on packages for OCs, Norplant, Depo-Provera, and IUDs, but does not require the statement about using a latex condom.
[Washington, D.C], Futures Group, SOMARC, .  p.Protektor is a condom introduced as a social marketing scheme in Mexico by SOMARC, with the Ministry of Health, and CONASUPO, a government-owned chain of grocery stores. Protektor condoms will be sold for half the average price of condoms, packaged in 3-packs of assorted colors and displayed in a dispenser in both the health and beauty aids section and at the check-out counter. CONASUPO is an ideal distributor because it is patronized by C and D class consumers, it accounts for 30% of grocery sales in Mexico, and it has the largest distribution network in rural areas. The Protektor campaign will begin with ads showing sports personalities during the World [soccer[ Cup in June 1986, featuring 18 weeks of advertising on radio, transit vehicles, and point of purchase displays. The theme "responsible loving couples" will be emphasized, with images of affection and intimacy. The Protektor campaign has been tested in 14 small 24-hour grocery stores in Cuidad Juarez, with an extremely positive consumer response. The campaign will be evaluated for both sales results, by a subsidiary of A.C. Nielson Co., and for consumer attitudes and awareness, by a subsidiary of Gallup Research. Mexico's population of 82 million, including 11.2 million fertile women, will double in 27 years. 51% of fertile women use contraception. Although 70% of people questioned know of condoms, 1.8% of contracepting couples use condoms.
ASBURY PARK PRESS. 1986 Jun 26;  p.US condom manufacturers have begun marketing their product directly to the people they most protect--women. "With the spread of sexually transmitted diseases and the growing number of unplanned pregnancies, women aren't just assuming that their partners will take the responsibility for birth control and disease prevention," said Stuart Gold, president of National Sanitary Laboratories Inc. in suburban Lincolnwood. Women account for over 40% of condom sales in this country, he said. The company's "Lady Protex" line of condoms--packaged in silver foil boxes with fuchsia or turquoise trim--is designed to be sold at the feminine hygiene sections of drug stores and supermarkets, spokesman Kevin Foley said yesterday. 7 months ago, a Minneapolis-based medical supply manufacturer, Mentor Corp. entered the condom market with the "Mentor Contraceptive" designed with the female buyer in mind. Mentor spokeswoman Jane O'Meara said the company would begin a national advertising campaign in September women's magazines. (full text)
DRUG STORE NEWS. 1986 Jul 7; 13, 15.Condoms are now displayed prominently to simplify self-selection and add impulse. This has made it easier for women to pick up a box of condoms as easily as they select their family's shampoo or toothpaste. Retailers and marketers of birth control methods report a dramatic increase in the number of women assuming responsibility for buying birth control products, particularly condoms. Some industry sources estimate that women buy close to 50% of the 800 million (units) of prophylactics purchased annually in the US. This trend, plus the fear of AIDS, herpes and chlamydia, have all created a 25% climb in condom sales, now pegged at $200 million/year. Once considered the least desirable form of contraception, the condom is becoming more fashionable. It is even stealing some sales away from foams and the pill, report buyers from Happy Harry's of Newark, Del., and Perry Drug. In order to grab more of women's purchasing dollars, drug chains are relocating condoms, moving them away from the pharmacy to space near the feminine hygiene department. Seattle-based Bartell Drug offers a 4-8 foot segment of condoms pegged on a gondola near female birth control products. People's Drug is in the process of moving condoms completely away from the pharmacy to pegged space in the feminine hygiene area. "Women buy them, so that's where we're putting them," explained Stephen Peck, vice-president merchandise manager at Peoples. Lynne M Pauls, of EF Hutton, attributes increasing condom sales to the demise of the IUD, as well as to the increase in female buyers and the threat of disease. Condom manufacturers are beginning to advertise in women's magazines such as Redbook; this is in addition to a different packaging approach begun a few years ago to show a man and a woman instead of the macho Trojan Warrior. Mentor, a new 2-piece condom, features a safety seal and is packaged in attractive pastel boxes. It is hoped this will appeal to women and therefore should be merchandised near other female birth control products. Despite the increase in alternatives in the condom market, there are still basically 2 top brands--Young and Schmid. Together, these brands control 90% of total sales. Some chains, however, are reluctant to cross-merchandise condoms with feminine hygiene products. This is due either to theft or to a desire to maintain a family image. (author's modified)
Working Woman. 1985 Oct; 68, 72, 74.Liberation in combination with legislation gives new life to condoms, which now find their way into the purses, brief cases, and shopping carts of increasing numbers of women. The number of female buyers of condoms has risen from 15% in the mid-1970s to perhaps as high as 40% today, thanks to the increasing number of women who are dissatisfied with contraceptive alternatives and a condom industry that is playing to its growing female audience with new packaging and marketing methods. The condom has a distinct advantage in an age when women are more concerned and knowledgeable about their bodies than ever before. The condom has no side effects. The $200 million-a-year condom industry enjoys a current growth rate in sales of about 12%. This is not too bad for a product that has been termed "16th century technology." Currently, Youngs, Schmid, and approximately 4 dozen other US condom companies mold, dry, test, roll and pack nearly 1000 condoms a minute, 400-500 million condoms a year. The Japanese buy 612 million condoms a year. Fewer than 15% of all US couples use condoms, which account for a quarter of the $800 million-a-year contraceptive industry. The growth in condoms was steady until about 3 years ago when it really started to move. There are 3 reasons for the growth spurt. In 1977, the Supreme Court struck down some lingering blue-nosed state laws that regulated who could buy condoms (not minors), where and why they could be sold (only in pharmacies for "disease control" rather than for contraception), how they could be advertised to the public (not at all), and where they could be displayed (out of sight). At the same time, a number of female contraceptive methods considerably trendier and more sophisticated than condoms fell into public, if not medical, disrepute. Finally, venereal diseases have grown in number to fill a category called sexually transmitted diseases (STDs) that includes more than 30 ailments. Condoms are the only contraceptives that also are effective venereal disease barriers. Consequently, condoms moved from under the counter to in front of it. Most notable of the condom industry's recent innovations have been unisex merchandising. It was decided that a lot more women would buy condoms if the packaging had femine appeal. With or without a yuppie clientele, the condom business is so healthy that existing advertising strictures have not hampered sales. Women are the primary purchasers of condoms in pharmacies and grocery stores.
Washington, D.C., Futures Group, .  p.The current status of the Caribbean contraceptive social marketing project, implemented by the Futures Group in conjunction with the Barbados Family Planning Association, is described. Contraceptive social marketing is a strategy in which commercial marketing techniques are used to promote the subsidized sale of contraceptive products. The contraceptives distributed in the Caribbean program are provided by the US Agency for International Development (USAID). Under a contract with USAID, the Futures Group, a private management and marketing consulting firm, provides financial and technical assistance for the Caribbean project. The project represents the 1st attempt to implement a social marketing project on a regional basis. The program is in the initial implementation stage and, at the present time, involves only Barbados, St Lucia, and St Vincent. Later, the program will be extended to Antigua, Dominica, St. Kitts and Nevis, and Trinidad and Tobago. Many of these countries requested their own social marketing program, due in part to their high rate of teenage pregnancy; however, the cost of setting up a separate program in each of these countries would be prohibitive. For this reason the regional approach was adopted. Many elements of an existing social marketing program in Jamaica were transferred to the Caribbean project after a study demonstrated that these elements were culturally acceptable to other countries in the Caribbean region. The Caribbean project distributes Pearl, a standard dose oral contraceptive (OC), Pearl LD, a low dose OC, and Panther, a condom. The USAID-developed package for Panthers was used in the program, and the Pearl package, used in the Jamaican project, was updated for use in the regional program. The regional advertising firm of Corbin, Compton Associates, based in Barbados, was hired to promote the products. The agency developed point of purchase materials and mass media messages, using the successful Jamaican slogan, "if you care about life." Since Caribbean youth rely on their elders for advice, a mature voice is used to present family planning messages over the radio. Panther commercials explain that real men take responsibility for family planning. Frank B. Armstrong, Limited, a firm experienced in distributing pharmaceuticals, was hired to distribute the program's products. In Barbados, the products are currently available in almost all pharmacies, in 1/3 of the country's supermarkets, and 1/2 of the country's small retail outlets. In the other 2 countries, they are available in selected pharmacies and small shops. Prices for the products are set differently in each country and are well below the price of commercially marketed contraceptives. The program was officially launched in February, 1984, by holding receptions for pharmacists and physicians in each of the 3 countries. Numerous meetings will be held in the future to promote the program among community leaders, health providers, and medical associations. The initial reaction to the program was positive in all 3 countries. The program includes a research component. The Operation Research Project of Tulane University, a USAID funded project, will be in charge of the research component. The impact of the advertising campaign will be monitored, and information will be collected periodically to assess the impact of the program on contraceptive usage and purchases. The research protocol is expected to be applicable to other social marketing programs outside the Caribbean region. The Futures Group's resident advisor for the project is Gail A. Washchuck, and the project's director is Enric C. Connolly. In view of the smooth initiation of the project, the launch date for the programs in the remaining countries may be advanced to early 1985.
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.
London, British Standards Insitute, 1979. 8 p.British Standard (BS) 3704, published in 1964 was one of the 1st standards dealing with the quality control of contraceptive devices. BS3704 had a 2nd edition in 1972, published to revise quality control techniques based on a cumulative sampling method applied to continuous production runs, to ensure that defective products did not exceed 0.5%. This document presents the 1979 revised edition of BS3704 with the requirements for condoms made of rubber latex. To test for design 1 specimen out of 10,000 must be tested for: 1) length, as determined by it being suspended over a graduate mandrel, which must not be less than 160 mm; 2) width, not less than 49 mm and not more than 56 mm; 3) thickness, no more than 0.160 mm for both smooth and textured condoms; and 4) weight, not more than 1.70 g for smooth and 1.90 g for textured condoms. 100 specimens over 10,000 must be tested for freedom from holes, as evidenced by the absence of leakage when filled with 300 ml of water and then rolled over absorbent paper. 10 specimens over 400,000, must be tested for tensile properties and for elongation at breaking point, and for color fastness. After each test a written test report is required. Rubber condoms must be packaged in sealed unit containers in such a way that the condoms are fully protected during transport and storage. Each individual container must carry the manufacturer's identification, batch number, number of contained condoms, and the date after which the condoms should not be used. Since rubber tends to deteriorate with age, condoms should not be kept in stock longer than necessary; as soon as a condom shows deterioration it should be destroyed.
[Unpublished] 1981 Mar 5. 6 p.The International Organization for Standardization (ISO) at present comprises the national standards bodies of 87 countries. Its objective is to promote the development of standards in the world with a view toward facilitating international exchange of goods and services and developing mutual cooperation in the sphere of intellectual, scientific, technological, and economic activity. The results of ISO technical work are published as International Standards. Technical Committees (TCs) are created by Council for clearly defined fields of activity. The Swedish International Development Authority (SIDA) proposed in 1972 to the Swedish member of ISO (SIS) that it set up an ISO/TC on condoms. The reasons for this request were the experiences SIDA has had when buying condoms for developing countries. In 1974 a TC, designated ISO/TC 157, was created to deal with standardizations of mechanical contraceptives. The 1st meeting of ISO/TC 157 was held in Stockholm in February 1975. At that meeting it was decided to give priority to condoms but to also deal with IUDs and vaginal barriers. Since the 1st meeting the TC has also met in New Delhi in November 1976, in Chicago in May 1978, and in Colombo in February 1981. As a result of the work, International Standards have been published for rubber condoms. The standards cover the following: determination of length; determination of width; determination of color fastness; testing for holes; determination of bursting volume and pressure; determination of tensile properties; packaging and labeling; and storage. A technical report on IUDs has been agreed upon and will be published in the near future. The TC has also agreed on additional test methods for condoms and has carried out some work on limit requirements on condoms based upon approved test methods. The TC has begun to discuss the problems related to certifications of condoms. The work that the ISO/TC 157 has carried out thus far will most likely result in simplified purchase and inspection procedures for condom consignments all over the world. All International Standards must be reviewed at not more than 5 year intervals.
Rubber condoms. Part 10. Packaging and labelling. International standard ISO 4074/10. First ed. 1980-12-01.
Stockholm, ISO, 1980. 3 p.Part 10 of ISO 4074 specifies requirements for the packaging and labelling of rubber condoms. Each condom shall be packed in an individual sealed container in hygienically satisfactory conditions. Several individual containers may be packed together in a consumer package. If a marking medium such as ink is used on a condom or on any part of a package directly in contact with a condom, it shall not be deleterious to the condom or harmful to the user. Individual containers or consumer packages shall be so designed, and made from such materials, that the condoms are fully protected during transport and storage and do not suffer any mechanical damage when the container and package is opened. When consumer packages are filled by other than the maufacturer, it is desirable that the packer maintains adequate records for product traceability. The packaging material shall not mildew in tropical climates and shall not attract insects. Each condom or individual container shall carry the following information: 1) the manufacturer's or distributor's recognizable identification, for example trade mark, name, abbreviated name; and 2) the manufacturer's identification reference for traceability, for example the batch number. Additionally, each consumer package shall carry the following information: 1) the manufacturer's or distributor's name; 2) the number of contained condoms; 3) the registered certification mark of the 3rd party certification body, where applicable; and 4) instructions for use; (Note--Alternatively these may be given on a separate leaflet within the package.). Furthermore, if required by the purchaser, standardizing body, regulating authority or manufacturer, each consumer package shall also carry the following information: 1) the batch number; 2) the expiration date (month and year) i.e. the date after which the contained condom shall not be used; and 3) instructions for storage, for example "Store in a cool, dry place away from direct sunlight or ozone". (full text)
[Unpublished] 1981 Dec. 45 p. (Contract No. NEB-00290-C-103700 EGYPT)The findings of a series of focus group interviews conducted by the Family of the Future in September 1981 on family planning methods and products are summarized in this report. Focus group interviews are conducted with about 8-10 respondents simultaneously. Using a discussion outline, a moderator guides the topics of conversation for about 90 minutes. 19 focus groups were conducted. The composition of these groups were current and previous users, spouses of users, and nonusers of oral contraceptives (OCs), tablets, and condoms. Across all user groups, participants felt that family planning was an important issue and that it was necessary for a man to have fewer children and to raise them well. A few of the women already had large families of 5-7 children but still considered family planning to be a good idea. Most respondents considered 2-3 children to be a good size family; 4-5 children was regarded as a large family. Several of the women who were nonusers of contraception had exposure to various family planning methods, both modern and traditional. Others had never used any contraceptive method. Women's responses for not using contraception differed from men's. In both user and nonuser groups, most of the men and women interviewed indicated that the decision to adopt family planning methods was a mutual decision between husband and wife, but many men felt that it is primarily the man's responsibility to decide. On the whole, the responsibility for using a particular method was considered to be the wife's. 5 focus groups were conducted to study the use of OCs: 2 with current users, 2 with previous users, and 1 with husbands of current users. Among both current and previous users, the OC was considered to be safer than the IUD and more reliable than the condom. All respondents thought OCs were very effective if used properly. Spouses of current users also noted that it caused certain side effects such as swelling, bleeding, and drowsiness. The quality and price of the product were considered more important than its packaging. OCs were considered to be widely available, and in regard to the new product, all the women liked the blue plastic compact. To study consumer perceptions of foaming tablets, 6 focus groups were conducted. Both previous and current users did not think the tablet was a very effective birth control method. Current users were satisfied with the tablet to the extent that the side effects were more tolerable than using OC or an IUD. Most respondents preferred the box of foil packages to the tube. Several respondents had heard about condoms on the radio or in family planning centers, and it was perceived as a safe and reliable birth control method. Packaging appeared to take 2nd place to the quality of the condom. Both men and women indicated that the men buy the condoms for themselves.
[Unpublished] 1980. Presented at the International Family Planning Association Seminar for Pharmacists, Dublin, Ireland, January 30, 1980. 8 p.In this discussion of standards and quality control in contraception, attention is directed to the following: scope; effectiveness; spermicides; diaphragms; condoms; labeling; evaluation; and stage of testing. The oral contraceptive (OC) is 100% effective, and the condom is not 100% effective. Couples limiting their families tend to use OCs most carefully, while couples spacing their families tend to use condoms less carefully. To make a fair comparison between OCs and the condom, it is necessary to compare like with like. In a recent UK study of married women, the 1st year pregancy rate was 5% for OC, 11% for the condom, and 14% for the diaphragm. For women married since 1970, contracepting after their 1st or 2nd pregnancies, the pregnancy rate was 4% for OCs and only 5% for the condom. Combining a good quality condom with a compatible spermicide is theoretically as effective as OCs. In regard to spermicides, their laboratory testing may bear practically no relation to their contraceptive effectiveness. It is plausible to suppose that spermicides satisfying the former International Planned Parenthood Federation (IPPF) Agreed Test are more effective contraceptives than other spermicides. When last submitted, all spermicides widely available in the UK satisfied the former IPPF Agreed Test. There are few national standards on diaphragms and none on other caps. The International Organization for Standardization (ISO) is attempting to fashion an international diaphragm standard. There are many national condom standards and an ISO technical committee is on the way to an international condom standard. It is important to distinguish between so-called electronic testing which is applied to all condoms, and sample testing, which is the concern of condom standards. Electronic testing seeks to eliminate condoms with holes or weak spots. The sample testing esentially checks the efficiency of that process, which may vary widely. Immediatly after electronic testing, the British Standard (1979) prescribes a sampling frequency of 1%. From each production quantum of 10,000 condoms, 100 random samples are taken and inspected for visible defects. The same condoms are then tested for holes. The Swedish State Standard (1972) prescribes the same test for holes, performed on condoms sampled from every batch imported into Sweden. Different standards also prescribe somewhat different tests for condom strength. Most condom standards prescribe dimensions. There are various requirements on labeling, and some standards prescribe instructions on storage and use. 99.5% freedom from holes is achieved, yet the main cause of method failure is a burst condom. It is guessed that at least 1 in 1000 good quality condoms burst, yielding a pregnancy rate of about 0.3/100 woman years.
Piact Product News. 1980 Oct; 2(2):1-2.Less-than-ideal environmental conditions, especially in developing countries with tropical or desert climates, prolonged storage times because of unpredictable supply and distribution, and inexperience with warehousing and logistics causing haphazard turnover of stocks can accelerate deterioration of condoms and render them unsuitable for use. As condom strength standards have never been related directly to failure during use, a Program for the Introduction and Adaptation of Contraceptive Technology (PIACT) study, in collaboration with Planned Parenthood of Seattle-King County, Washington, was conducted to determine the actual relationship between condom strength and failure during use (see July 1980 issue of Contraception). The study found that: 1) air burst test parameters can effectively and sensitively measure changes in condom strength; 2) condoms produced by Western industrial standards exceed by a wide margin the minimum strength required for effective use; and 3) stored condoms should not necessarily be thrown out if they are uniform in strength, even though they fall below accepted standards for new condoms. The study also brought out the issue of condom packaging. The potent deteriorating effect of ultraviolet light on condoms is well-known, and it is therefore suggested that condoms be packaged in foil or opaque laminates on both sides. A separate study requested by the U.S. Agency for International Development investigating the relationship between the 2 tests for condom strength (air burst standards as used in the PIACT study and tensile strength measurements) showed that air burst data and tensile strength parameters closely reflected the same characteristics, thus providing support for the use of air burst strength measurements for predicting useful life of stored condoms.
[Unpublished] 1982 Feb 22. 16 p.Family of the Future (FOF) conducted between December 14 1981 and January 7 1982 interviews with 394 people at 10 pharmacies and 3 clinics, to determine awareness of family planning methods. Among the 394 people interviewed 100 did not use contraception, 98 were condom users, 100 were oral contraceptive (OC) users, and 96 were vaginal foaming tablet users. Mean age of males was 34.7, and mean age of OC users was 31, of foaming tablet users was 30, and of nonusers was 28. In general, men were better educated than women. 44% of condom users said they liked them because of lack of side effects; 1/3 said the condom reduced sensitivity; 90% of users knew the Tops brand, followed by the Tahiti brand. 99% bought condoms at a pharmacy; 7 out of 10 would buy Tops; 4 out of 10 said they first bought a condom under advice of the pharmacist. 76% preferred the inner package to be covered on both sides; 2/3 of respondents said they had seen advertisements about Tops. 49% of OC users thought it was the most effective method; mean duration of pill use was 5.3 years. 33% had first heard of OCs from a doctor; 90% of users took the pill correctly and the most common side effect was headache. 50% of women said neither a doctor nor a pharmacist had ever discussed side effects with them. Anovlar was the best known brand, and 95% of users were satisfied with the brand they used. Users of tablets liked the lack of side effects best, although 6 out of 10 did not like the bubbly, warm, and burning sensation after insertion; 4 out of 10 users said their husbands could feel the tablet during intercourse. 90% of users had heard of the Amaan brand, and 82% currently used it. 9 out of 10 users bought the tablets at a pharmacy, and 90% said they had read the instructions; 4 out of 10 had heard of the tablets from a doctor. Among nonusers of contraception 3 out of 10 were pregnant, 2 out of 10 were breastfeeding, and 2 out of 10 said they wanted more children. 6 out of 10 had previously used the pill, 1/4 the IUD, and 20% the condom. Nonusers reported that they would start family planning in about 1 year. 6 out of 10 said they would use the IUD, 3 out of 10 the pill, and less than 10% the tablet. The pill was chosen because of its effectiveness, but prospective users knew they would experience some side effects. 90% of prospective IUD users also were expecting side effects. The IUD was chosen mostly because of its effectiveness and because it does not need sustained motivation. Over 90% of users would like more information about family planning methods; about 7 out of 10 respondents knew of FOF.
Rubber condoms. Pt. 1. Sampling plans and limit requirements. Draft international standard ISO/DIS 4074/1; ISO/TC 157 NIZZE.
Stockholm, ISO, 1982 Mar 19. 5 p.This section of ISO 4074 specifies the sampling plan and limit requirements for rubber condoms. Condoms are produced in identifiable lots manufactured under the same conditions and at basically the same time. There are about 150,000 condoms in each inspection lot which are of the same appearance in 1 standard width, length, and surface type. Condoms are made from good quality natural rubber latex, transparent, translucent, opaque, or colored. There are 2 classes of condom, 52 mm and 49 mm wide, and 2 types, smooth and textured surface. Design requirements are specified in tabular form. As far as physical requirements are concerned, tensile properties are presented. When resistance to storage is required, the condoms shall be tested as per ISO 4074/7. As to bursting volume and pressure, each inspection lot shall be sampled per ISO 2859, for normal inspections. The bursting volume shall be min 10 cu dm and bursting pressure min 0.7 kPa for both classes of condoms utilizing a 2.5 AQL. Freedom from holes, color fastness, and sampling and requirements for packaging and labelling are also specified. Inspection lots of condoms may be accepted for adherence to this standard only if they satisfy all requirements listed. Those which do not cannot be considered as meeting the ISO Standards for condoms.
IPPF Medical Bulletin. 1983 Jun; 17(3):2-4.At least 12 countries have regulations for condoms, and because of the complicated regulations relating to condoms the International Organization for Standardization (ISO) was asked to create a committee for contraceptives. Its objective is to promote the development of standards throughout the world to help the international exchange of goods and services. Following discussions between the World Health Organization (WHO) and ISO it was decided in 1974 to establish a technical ISO committee that would deal with international standards for mechanical contraceptives, comprising condoms, diaphragms, and IUDs. It was also decided that spermicides and oral contraceptives (OCs) should be excluded from the ISO effort, but that they should fall within the responsibility of WHO. The committee, entitled ISO/TC 157 Mechanical Contraceptives, was represented by 35 member countries in 1982. The object of standardizing condoms is to obtain a satisfactory quality that can be accepted throughout the world. To achieve that purpose, acceptable test methods and associated limit requirements and values must be determined, along with rules for storage, packaging, and labeling. The most important factors in determining condom quality are the need to reach agreement on an acceptable number of holes in the condom and the ability to establish limit values for the mechanical properties of the condom. Specific requirements regarding dimensions, resistance to storage, packaging, labeling, and appropriate storage are also important. Up to 1982 the work of ISO for condoms resulted in 8 published international standards, of which 6 deal with test methods, 1 with packaging and labeling, and 1 with storage. Agreement has also been reached within the ISO committee on an additional 3 draft standards. Due to the comparatively small use of diaphragms, standardization efforts in this area do not have the highest priority. ISO/TC 157 has formulated 10 drafts which are being prepared for distribution to the ISO member countries for purposes of voting. 7 of these standards deal with test methods, 1 with sampling and requirements, 1 makes storage recommendations, and 1 refers to packaging and labeling. A working group for standardizing IUDs was established in 1976. It was agreed within ISO/TC 157 after almost 3 years to publish a Technical Report (TR 7439) for IUDs. The report deals with such things as the definition of IUDs, general requirements for type approval, batch inspection, storage recommendations, and packaging and labeling. The report shall constitute the basis for continued standardization efforts for IUDs.
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.
Washington, D.C., Futures Group, . 72 p. (Project No. AID/DSPC-CA-0087)This study of commercialization of contraceptives in Port-au-Prince, Haiti was conducted to generate information about packaging design, logos, names, colors, and prices that could influence potential users to buy contraceptives and to determine factors related to uses of methods that could influence their choices. Specific study objectives were as follows: determining certain characteristics of the market such as incidence of contraceptive use and user's age and socioeconomic class; determining the list of benefits sought by users and potential users of contraceptives, the ideal contraceptive, usage information, and incidence of selling price; identifying certain factors, i.e., needs, desires, opinions of present services; and determining preference for brand name, packaging design, logos, and colors of contraceptives. A total of 300 interviews were conducted--100 women for the oral contraceptives (OCs), 100 women for the foaming tablets, and 100 men for the condoms. The following were among the study findings: in general, all respondents were aware of 1 contraceptive method; from 100 interviewed, 82% knew about OCs, and 85% of the 82 were past users; 71% of the present OC users (49) purchased their pills at a pharmacy, and 21% preferred the Ortho Novum brand; 24% of the 82 ever users would prefer 2 cycles in a package, and the same percentage preferred more than 3 cycles; among the 100 interviewed regarding the condom, 68% were past users of a contraceptive method from which 74% (50) were condom users, and 69% were presently using the condom; in general, reasons given for using condoms were mainly easy availability, no side effects, no medical visit, and disease prevention; the benefits sought from the ideal condom were thin, resistant, inexpensive, and available by unit; among the 69% current condom users, 29 buy them in a pharmacy or small shop and most of them asked for Tahiti brand; respondents said they are willing to pay anything less than US$1 for good quality condoms (they indicated that Tahiti was "not good quality"); 70% of those interviewed about foaming tablets knew about this method, but only 20 respondents were past users of the tablets and 35 were actual users; most foam tablet dropouts considered the method inefficient; reasons given by respondents for having chosen foaming tablets were recommended by relative or friends and do not require daily utilization; and 66% of foaming tablet users bought their products in a pharmacy.
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)