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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.
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. 385-463Estimation of Thailand's contraceptive market potential in the light of the country's socioeconomic background; family planning efforts; commercial market for contraceptives and attitudes of manufacturers and consumers indicate that government regulations regarding Thai import, trade and pharmaceutical activities are generally not very restrictive compared with those of other developing countries. Problems encountered by pill manufacturers are the low retail prices of pills (the Schering Company plans to increase retail prices through local production of the pills) and the possibility of a massive free contraceptive distribution through government family planning programs. Overall, trade prospects for the pills are seen by all concerned as bleak. In the private sector, no major cultural factors are expected to hamper contraceptive sales. There is in fact a high level of interest and motivation among Thai women to practice contraception due to family tradition and their participation in the labor force (in 1966, it was estimated that 42% of the female population was actively employed). Problems in marketing the condom include the "illicit sex" image associated with its use and the widespread belief regarding the inferiority of local products to improted products. Empirical evidence indicate tht Thailand's potential market for condoms consist of about 1,500,000 males and a corresponding annual market of 180 million condoms, or 10 times that of the current market. However, in the light of the limited purchasing power of the Thais and a free government family planning program, more realistic estimtes would be an annual sales potential of 86 million pieces, or a 400% increase over the current market.
Columbia, Maryland, Westinghouse Population Center (AID Con tract #csd/3319). 1974 Apr; 164.The Westinghouse Population Center, Columbia, Maryland, under contract to the United States Agency for International Development, has investigated the current and potential distribution of contraceptives through available commercial channels in Turkey as well as in 8 other developing nations. It is believed that commercial sector contraceptive distribution can have a significant effect on fertility patterns. The purpose of the investigation is to identify and evaluate the existing contraceptive market, the channels of distribution, and the potential for increasing private sector participation in expanding the availability and usage of contraceptive products. The private sector currently supplies a larger percentage of the couples using contraceptives in Turkey than does the public sector. The private sector's distribution capability is such that it can reach people who do not reside within a reasonable distance of a pharmacy or clinic as well as make a wider range of products and information available so that consumers can choose the brand and/or method they wish to use. Included in the findings of the report are recommendations for action. It is recommended that the government eliminate duties and taxes on the importation of finished condoms and of raw materials for producing oral pills and vaginal contraceptives, streamline the procedures for importing condoms, and increase the number of retail outlets for contraceptive products. The government and manufacturers should initiate physician education programs. At the manufacturer's level, pharmacists and other retail outlet operators who sell contraceptive products need to be supplied with accurate information. Mass media should be used at the consumer level to inform the public about the proper use of contraceptives, for the majority of couples has limited knowledge of how to obtain and use contraceptives. Promotion of contraceptives should be targeted to both male and female audiences. A research strategy should be incorporated which makes a series of quick evaluations of various elements of the program possible.
Estrogen dose in oral contraceptives: FDA committee examines safety and utility of 50 mcg estrogen OCs.
CONTRACEPTION REPORT. 1994 Mar; 5(1):10-3.In July, 1993, the US Food and Drug Administration (FDA) sent a letter to manufacturers of oral contraceptives (OCs) to inform them about reports of reduced risk of thromboembolic events linked to OCs with less than 50 mcg estrogen, and to ask them to voluntarily withdraw 50 mcg OCs from the market. In October, 1993, FDA's Fertility and Maternal Health Drugs Advisory Committee met to discuss the relative safety and utility of OCs with 50 mcg estrogen. 15% of women at least 45 years old who were using OCs were taking OCs with 50 mcg estrogen. Some gynecologists justified continuation of the higher-dose OC in this age group by claiming that the high dose was needed to treat breakthrough bleeding, which in turn improves user compliance, continuation, and contraceptive effectiveness. Since rifampin, phenytoin, phenobarbital, griseofulvin, and (possibly) long-term use of tetracycline reduce contraceptive effectiveness, physicians prefer 50 mcg estrogen OCs for women taking them. One committee member was concerned with the number of 45-year-old or older women, who are at the greatest risk of a thromboembolic event, who use 50 mcg estrogen OCs without good cause. The committee's consumer representative considered this to be a physician education problem. A review of the literature showed no clear, significant increase in the risk of thromboembolic events in women who use 50 mcg OCs. One physician pointed out that continual reduction of the estrogen dose to eliminate the small or nonexistent cardiovascular risks reduces some benefits, especially protection against ovarian and endometrial cancers. Even though the committee did not unanimously agree that 50 mcg estrogen OCs are less safe than OCs with lower estrogen doses, they did agree to recommend more emphasis and prominence on current OC labeling about prescribing the smallest estrogen dose needed to achieve contraceptive efficacy.
ADVANCES IN CONTRACEPTION. 1992 Oct; 8 Suppl 1:57-65.All women in the UK have access to family planning (FP) services via general practitioners (GPs), fee paying clinics, and National Health Service FP clinics. FP services are adequately publicized and open late in the evening. They consider patient education as high priority. Nevertheless recent studies indicate that patient knowledge of oral contraceptives (OCs) is lower than expected. Most large clinical trials reveal OC failure rates are about 3% yet subjects tend to be married women who have the lowest failure rates. Rates from clinics are up to 6%. Among US adolescents and women from developing countries, failure rates may reach 13-20%. Despite comparable rates of sexual activity among adolescents, pregnancy rates among European adolescents are much lower than those among US adolescents (50% lower in Sweden and 85% in the Netherlands). Research in family planning clinics in London show that many women do not even have basic knowledge about OCs, but they had greater knowledge than women who received counseling at GPs offices. Adolescents of lower socioeconomic status who fear real or perceived side effects, use the low dose OCs, and served by a poor quality delivery system which provides little or no educational counseling are at highest risk of poor OC compliance and OC failure. Manufactures should include start days an sequence and package OCs in a small package. After identifying what patients are at risk of OC failure, physicians must realize that people learn in a safe and calm environment and by doing. They can only remember 3 messages/session. Physicians need to pay attention to the patient, to assume nothing, and to hand the patient written facts about OCs. Education comes down to teaching facts, teaching skills, and answering questions. The most powerful means of patient education is the mass media.
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)
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE. 1980 Mar; 29(2):285-90.Sucrose-electrolyte oral therapy packets (1 liter) were distributed to a rural Bangladesh population of 157,000 by community-based workers and this effort was evaluated. A similar population of 134,000 served as a comparison group. The locally-produced packets showed satisfactory chemical composition with a shelf-life of up to 3 months and a cost of U.S. $.05. After 4 months, the workers were distributing an average of 70 packets/1000 population/month. Most patients used 1 packet/diarrheal episode; 13% of children used 2 packets, and 15% and 8% of adults used, respectively, 2 and 3 packets. The electrolyte composition of the oral fluids prepared by fieldworkers and mothers showed substantial variation, but no hyperconcentrated solutions were noted. When comparing the hospitalization rate from the 2 study areas, it appears that there was a 29% reduction in hospital stays for diarrhea during the 4-month distribution period. (Authors' modified)
Springfield, Virginia, National Technical Information Service, September 1975. (FDA Contract No. 223-74-8058) 412 pIn a national probability sample of 1720 women aged 18-45 currently using oral contraceptives, it was found that patient-package inserts for this drug are clear and useful. Applied Management Sciences, Inc. undertook the study of oral contraceptive users to determine their perceptions of the patient-package insert and information booklet available with the drug. Specific objectives were the following: 1) whether patients read and retain the information provided; 2) how style of the insert affects understanding of drug use; 3) if and how patients obtain booklets cited in insert; 4) how a sample of patients has used the information; 5) how availability of information affected patient/physician communication; 6) what other information sources have proven useful to oral contraceptive users; 7) what has the decision-making process for users about brand selection and termination of oral contraceptive use; 8) whether such inserts on other drugs are desired by this sample; 9) the extent of insert information preferred; 10) whether a relationship exists between previous oral contraceptive user responses and time since last pill use; and 11) whether the type of insert affects consumers perception of the information. An overwhelming majority in the survey believe patient information should be available for other prescription drugs. Of the 93% who reported receiving the insert, 88% had read it. More informaiton was desired on common side effects, warnings, and precautions. Of those who had access to both an insert and a booklet which contains more detailed information, 67% preferred the booklet and 18% the shorter insert.
Journal of the American Medical Association. March 29, 1976; 235(13):1331-1336.828 questionnaires designed to assess attitudes, knowledge, views and sources of drug information on oral contraceptives (OC), with particular attention to the role of the patient-oriented package insert, were analyzed and results presented. The questionnaires were given to 6 female subgroups: undergraduate students enrolled in a sex education course (80), 2nd-year nursing students (67), undergraduates (97) and 2nd-year nursing students (45) at the University of Rochester, patients attending the Obstetrics-Gynecology outpatient clinic at Strong Memorial Hospital (100), and outpatients attending the Planned Clinic in Rochester (439). Respondents were divided into 3 groups--those presently using OC, past users, and nonusers. Most frequent OC used was associated with single females 25-29, white collar, 16 years education with a family income of $3000-$6900. 52.8% had used OC less than 2 years. 19.1% and 12.4% reported discontinuing OC because of side effects or fear of side effects respectively. 64.4% of OC users were aware of package label and 91.2% of these had read it. 86.4% found the label helpful. Patient knowledge showed total knowledge correlating significantly with age, number of children, years of education, total family income, OC use and having read the insert (P less than .01). "Side effect" knowledge had a singificant correlation of P less than .05 with these variables and "use" knowledge P less than .05. The physician was considered to be the preferred source of prescription drug information. 61.5% considered OC fairly safe and 80.4% considered them very effective. 32.6% of present users, 57.9% of past users and 56.1% of nonusers considered the risk to their health of OC greater than the benefit of its use. It is suggested that a balanced presentation in printed sources of risk-benefit, consistent with scientific knowledge, would help the patient understand OC.
[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.