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Obstetrics and Gynecology. 2012 Apr; 119(4):772-779.OBJECTIVES:: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS:: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS:: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION:: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE:: II.
[Research Triangle Park, North Carolina], FHI, .  p. (Research Brief on Hormonal Contraception)Over-the-counter provision of oral contraceptives by pharmacists is a safe, effective, and practical way to distribute this popular contraceptive method in Jamaica, according to research published in the journal Studies in Family Planning.
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)
Contraceptive Technology Update. 2004 Feb; 25(2): p..This month may well mark a milestone in women’s health if the Food and Drug Administration (FDA) follows the recommendation of two of its expert advisory committees to approve the over-the-counter (OTC) sale of Plan B, the levonorgestrel-only emergency contraceptive (EC). In a joint meeting of the FDA’s Reproductive Health Drugs and Nonprescription Drugs Advisory committees, members voted 23 to 4 to recommend OTC sale of the drug. The final decision rests with the FDA’s commissioner, Mark McClellan, MD, MPH. While the FDA doesn’t always follow its advisory panels’ recommendations, it would be “surprising” if it did not in this case, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University. “There wasn’t much opposition, and there was considerable support” for making the EC drug available on retail pharmacy shelves, says Trussell, who was a member of the FDA joint committee. (excerpt)
[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.
Columbia, Maryland, Westinghouse Health Systems (AID/pha-C-1063). 1977 Dec; 68.In July 1974, Westinghouse Health Systems began the process of establishing a contraceptive retail sales program (CRS) to market condoms and oral contraceptives in Jamaica. The program, designed to utilize existing retail distribution systems, had as its major focus the development of indigenous resources to augment the existing clinic activities of the Jamaica National Family Planning Board, and centered on 5 major areas: 1) advertising and promotion; 2) product pricing and packaging; 3) distribution; 4) consumer and retailer education; and 5) program evaluation and monitoring. Initial research was aimed at educating the public, distributors, and retailers in the availability, usage, and potential side effects of oral contraceptives. A major advertising campaign involving radio, television and the press was directed at promoting the 2 contraceptive brands - Perle oral contraceptives and Panther condoms. In September, 3 years after implementation, management of the program was turned over to the Jamaican National Family Planning Board. Annual program sales had reached 184,000 cycles of pills, and 880,000 condoms through 267 Perle outlets and 1108 Panther outlets, nearly doubling and tripling pill and condom sales. Introduction of the new brands has had no effect on sales of competitive brands, nor has there been a negative impact on distribution of condoms and oral contraceptives through the public clinic sector. In addition, the cost per acceptor has been less when compared to costs per acceptor in the public sector clinics. By 1979, the projected costs per acceptor will be $262 in the CRS program versus $32.73 in the public sector program.
Social Science and Medicine. 1991; 32(11):1201-18.The 3 drug distributing systems in Africa, private commercial, private non-profit, and public, are described, and issues involved in improving efficiency and rational use are exposed. The private pharmacy sector in Africa is largely located in cities, with retail prices multiples of those charged for name brands in the West. It includes pharmacies, drug shops, injection rooms, and drug peddlers, who obtain their supplies from wholesale and retail sources, and frequently pilferage from public supplies. The private non-profit system, largely missing health agencies, are often well-managed by regional drug procurement associations. The public sector consists of government and para-public enterprises and their distribution facilities. Supplies are limited, especially at the end of the transport chain, because of deficit financing and logistical obstacles. It is best to employ expatriate managers who are immune to local corruption. The most effective points to improve efficiency in drug supply are in procurement: to select generic drugs, take advantage of credit for certain brands, avoid non-essential, low priority, and expired drugs. Great savings could also be obtained by sound logistics, proper storage, and avoiding local purchase of emergency supplies. Rational use of drugs can be improved by consistent, conservative prescription, kits for managed care, and for AIDS especially, management protocols. Most African countries have their own pharmaceutical production facilities, but these have lost money because of the high cost of imported raw materials, technology and personnel. These facilities could best be used to formulate or re-package generics bought in bulk for local needs, to produce intravenous fluids, and to make simple products such as ointments at a profit. It might be efficient to produce essential drugs under regional agreement and quality control, avoiding duplication. Some concerns peculiar to Africa are self-medication, "cultural re-interpretation" of Western medications by users and traditional practitioners, sparse populations without transportation infrastructure, counterfeit drugs, and an entrenched informal system of private sales of non-essential and ineffective therapeutic agents. AIDS is an added burden to an already strained health system.
[Unpublished] 1989 Nov.  p.The foundations of a contraceptive social marketing project aimed at increasing the availability and use of condoms among urban, married, low-income men in Morocco are described. Aiming to sell the condom through commercial retail outlets with the goal of increasing overall prevalence of condom use, the Moroccan Social Marketing Project (MSMP) is the 1st major contribution by the commercial sector in the national effort to increase participation in family planning. 18 months of research on the Moroccan condom market and promotion strategy served as initial groundwork for the project. Specifically, pre-campaign surveys on contraceptive usage, attitude, and pharmacies; product name and pack development research; and advertising positioning research and message testing were conducted. Low condom usage was found in Morocco, with <5% of urban, married, male contraceptors using condoms; nationwide, <1% of women and their partners used condoms. Using radio and point of purchase advertising in urban and peri-urban pharmacies, a marketing strategy was developed urging non-contracepting men to choose condoms once they decided to begin using a contraceptive method. Focus was placed upon shifting the image of the condom away from its association with illicit relationships, encouraging the continued strong male support of and role in family planning, and choosing an appropriate product name, advertising positioning, and price through the assistance of focus groups' suggestions.
Jakarta, Indonesia, Survey Research Indonesia, 1988 Sep. 40,  p. (SRI - 737)This report of a survey of awareness, usage and attitudes of 2106 men from Jakarta, Surabaya, Medan and Bandung, Indonesia, featuring condoms and the Duo Lima condom in particular, by Survey Research Indonesia, comparing 1988 to 1987, consists of 27 tables and 2 conceptual maps. Many of the data compare location or economic class. Unaided awareness of condoms had decreased from 20 to 16% overall between 1987-1988, while knowledge of vasectomy and Norplant had increased. Use of condoms as the main method fell from 7 to 5%. 10% have ever tried condoms. The main source of purchase was the Apotik (50%), drug store (195) and puskesmas (12%). The most common condom pack size purchased was 12, followed by 3 and 6. Men described condoms' "messiness" as their worst drawback. Most users tried condoms for <1 year, indicating falling off of use. Awareness of the Duo Lima brand has increased to 48%, up from 43% in 1987. It was the 1st brand mentioned by all men; 69% recalled Duo Lima advertising, primarily on radio, on billboards, and in newspapers. Duo Lima was the leading brand with 39% of subjects using it. Perceptual maps placed Duo Lima as an attractive, modestly priced, well advertised brand, the right size, and best suited for family planning.
Use of a pilot test market to determine packaging and price levels for commercial contraceptives in Liberia.
Washington, D.C., The Futures Group, 1989. 5 p. (SOMARC Occasional Papers No. 8)A "test market" was conducted to assist a contraceptive social marketing project in Liberia. A condom (Protector), a pill (Norquest), and a vaginal tables (Secure) will eventually be marketed. A test was done to see if selling the product without a package would help sales. A test to find the highest price was also done. The 2 objectives were to: 1) determine pricing levels for all 3 products; and 2) to determine packaging for the condom. 54 pharmacies and medicine stores in Monrovia, Liberia and 3 smaller cities (Ganta, Buchanan, and Gbarnga) participated in the test market. The outlets were then matched for size and location. In June, 1988, test places were given supplies. Further purchases were recorded. Sales levels were determined by sales audits through September, 1988. 2 pricing choices were tested for each of the 3 products; a standard price, and a high price. Any 1 outlet only carried products at 1 price. The pill (Norquest) sold better at the standard price. Price did not affect sales for condoms or vaginal tablets. Therefore, it was decided to sell the pills at the standard price; condoms would not be sold at the high price, and vaginal tablets at the standard price, since the product was not well known in Liberia. 3 packaging choices were tested for the condom. They were sold either packaged (in professionally done packs of 3), in bulk (sold directly out of the shipping box of 100 in any quantity), and mixed (condoms both packaged and in bulk). Condoms sold best with the mixed option (in both bulk and packaged). Pilot studies are recommended.
DEVELOPMENT COMMUNICATION REPORT. 1980 Jul; (31):3-4.The success in social marketing of the PROFAM brand of subsidized contraceptives, by a nonprofit private institution that supports the Mexican government program, is related here. PROFAM began in 1978, when half of contraceptives were purchased commercially from drugstores: they were neither economical, consistently distributed, nor advertised. Comprehensive market research revealed that a great demand existed. It generated information for choice of items to market, package design, and instructions. In 1979, pills, condoms, foam, cream and vaginal suppositories, all locally produced were distributed. A serious problem initially was the impropriety of using the word "contraceptive" in the media. The first phase of advertising targeted newspapers. After 3 months, 40% of Mexico's drugstores carried PROFAM. The second phase of advertising, in radio, magazines and newspapers, approached consumers with information tailored to the specific socioeconomic group involved. The third phase, geared to rural areas and general stores, concentrates on advantages of each method. Other aggressive aspects of the campaign include house to house sampling and a mail-in question and answer service. Evidence of success in broadcasting the PROFAM message is the frequent reference to PROFAM in jokes in the media and even in graffiti. The government's goal is to reduce the growth rate form 2.9 percent annually to 1 percent by 2000.
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.
In: National Council for International Health [NCIH]. Pharmaceuticals and developing countries: a dialogue for constructive action. Washington, D.C., NCIH, 1982 Aug. 21-6.The Pharmaceutical Manufacturers Association (1972) has endorsed the underlying objective of the Action Program on Essential Drugs which is to provide and improve access to needed drugs and vaccines through public sector programs--government programs--to people in the least developed countries who are now unserved or underserved. Additionally, the industry has endorsed the concepts embodied in primary health care. Although the industry has an important role in these efforts, the principal issues and responsibilities involve public policy decisions, not the private sector. The private sector is an important factor but not the final authority in determining policy directions. Governments have a particular responsibility to set priorities and allocate resources. There has been too much emphasis on the supply of drugs and not enough on the need to improve the health infrastructure. Unless a distribution and delivery system exists, drugs are of little use. In most instances the resources required to establish this infrastructure are far greater than those needed to purchase drugs. The industry feels strongly that any efforts on the part of the World Health Organization (WHO) and national governments to implement this action program should not interfere with existing private sector operations. Industry has expressed its concern about the action program in several different ways. Possibly the most recent and significant one is through the International Federation of Pharmaceutical Manufacturers Association. Issues have been raised recently concerning the industry's marketing practices for the 3rd world, i.e., the sale of drugs overseas which are not sold in the US and labeling differences between the US and the developing countries. The fact is that the health conditions, disease incidence, and medical judgment of public health and drug authorities vary substantially from country to country. This is the result of different levels of sanitation, nutrition, medical infrastructure, the dispersion of doctors and pharmacists, racial characteristics and other factors. It is arrogant and paternalistic to insist that 1 country's decisions in this area are somehow superior to another's. It is also potentially dangerous in health terms to assert that the standards of 1 particular country should be applied to all. In 1976 the International Federation adopted a policy statement on the international labeling of drugs. The Association position is that the important information concerning side effects and indications should be communicated in the developing countries.
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.
An overview of pharmacies, pharmacists, and the pharmaceutical distribution system in Egypt. Executive summary.
Washington, D.C., The Futures Group, 1982 May 5. 23 p. (Contract NO. AID/DSPE-CA-0087)The project purpose was to document the actual role of commercial drug suppliers, pharmacies, and pharmacists in Egypt, to determine bottlenecks or constraints in pharmaceutical distribution at the macro and micro levels, and to make recommendations on how to more effectively utilize the distribution system in the delivery of primary health care services and products. Phase 1 of the study involved interviews by Futures Group senior staff with representatives of the Egyptian government involved in the regulation of pharmacy practices and pharmaceutical distribution; representatives of pharmaceutical importers, manufacturers, and distributors; and the administration of a structured questionnaire to pharmacists attending a conference in Alexandria. Phase 2, conducted by a medical anthropologist, involved 10 days of in-depth observations and discussions with pharmacists and clients in urban and rural settings. The objective of the government's regulation of the pharmaceutical industry is to provide medically important and widely used drugs at a price which will make them available to the large majority of the population. In meeting this objective the government has constructed a set of disincentives for the broader role that the pharmaceutical distribution system could play in meeting the primary health care needs of the Egyptian population. Study findings are reported in the following categories: industry structure; regulatory structure; production, importation, and exportation of pharmaceuticals; distribution and marketing; pharmaceutical industry capital stock and investment; pharmaceutical pricing; consumption of drugs; public sector expenditures on drugs; number and distribution of pharmacists and pharmacies; education and training; pharmacy operations; the pharmacist and national health issues; the pharmacist's role; and relations with physicians. Egypt's pharmaceutical industry has developed primarily as public sector companies. The Council for Pharmaceuticals, Chemicals, and Medical Equipment is the primary pharmaceutical regulating agency. 3 committees serve the Council to regulate various aspects of the industry. About 8 of every 10 drugs, in terms of value consumed in Egypt, are locally manufactured or packaged. The Egyptian Company for Trade and Distribution of Pharmaceuticals (EGYDRUG) is the public company charged with general importaion of finished products and wholesale distribution of both local and foreign drugs. The expenditure on pharmaceuticals in Egypt has been increasing at an annual rate of 20-25%. Government expenditures on drugs appear to be somewhat less than proportional to the other areas of health care provided by the government and which are complementary to the use of drugs. At the end of 1981 the number of pharmacists who worked in hospitals, private and government sectors in Egypt was approximately 16,070. The general role of the pharmacist requires an active participation in both the delivery of health care services and in the dissemination of health knowledge.