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[Unpublished] 1993 May.  p.The Decore/Synchro Media Company in Kathmandu has submitted findings from market research on the promotion strategy in Nepal for the low-dose oral contraceptive Nilocon. Based on the research, the recommendations fall under four topics: package design, story board, tune, and instruction sheet. Consumers and pharmacists preferred the package design with flowers. Some suggested variations of the design include flower package design for the brand targeting lower income women, bird design for the brand targeting middle to upper income women, four flowers instead of three to signify ideal family size, the name of the product in Nepali, more prominent display of high quality low dose text, darker background color, and nonuse of the family planning logo. Consumers and pharmacists most preferred the plant spacing story board followed by women in development and testimonials. Yet, the general health and prosperity message of the women in development and testimonials story boards had a wider appeal. Some suggested changes to the women in development story board include: more clear product-related benefits (e.g., birth spacing can improve mother's socioeconomic status), use of Nepali, the women depicted should not meet at the beauty shop but have a more casual encounter, an endorsement by a physician or credible health worker, more colorful pictures, and smiling faces. The second jingle was preferred. A suggested change in the style of accompanying music was use of the traditional musical instrument madal. A female voice should be used to say the closing sequence (Loved by most women, high quality contraceptive--Nilocon, Nilocon). Study participants preferred the first instruction sheet with many visuals combined with the text.
Integrating Depo-Provera in Nepal's social marketing initiative: what mechanisms are being developed to ensure high quality services?
SOMARC III HIGHLIGHTS. 1993 Dec; (8):1-2.The Social Marketing for Change (SOMARC) project and the Contraceptive Retail Sales (CRS) Company in Nepal, with assistance from the Association for Voluntary Surgical Contraception (AVSC), are introducing Depo-Provera (DMPA) in 280 medical shops in Kathmandu Valley. At the first training session for Nepalese trainers, which was held in September, 1993, SOMARC and CRS provided an overview of DMPA administration. This included product features and benefits, product side effects and their management, precautions, client screening, injection techniques, infection prevention, syringe disposal, counseling, and myths and misconceptions about injectable contraceptives. Upjohn (the manufacturer of Depo-Provera) provided technical support and materials for this training session. CRS intends to train at least 1 staff person (medical staff or paramedical assistant) at each medical shop in the pilot program. Distribution of the product will be monitored. To insure proper technique and infection prevention, DMPA will be packaged with a disposable syringe, an alcohol swab, a consumer acceptor card, and product information. Consumer advertising and materials at the point of sale will inform consumers that the intact package should be opened in their presence. Posters and mass media will be used to inform the consumer of the provider's recommended screening process. Booklets will contain information regarding conditions requiring medical care. Consumer acceptor cards will list the date of the next injection as a reminder. The Nepal Fertility Care Center (NFCC), a private family planning association with facilities in the Kathmandu Valley, will provide further information or follow up to clients when necessary. NFCC physicians, who have been trained by AVSC, will evaluate medical shop personnel administering DMPA. The program is expected to be launched in mid 1994.
CONTRACEPTION REPORT. 1993 Nov; 4(5):14.In 1993, the Food and Drug Administration (FDA) issued new labeling guidelines for oral contraceptives, intrauterine devices (IUDs), implantable and injectable contraceptives, and natural membrane condoms. The prevalence of sexually transmitted diseases (STDs) and the AIDS epidemic prompted the FDA to take this action as part of an on-going education effort to reduce the risk in sexually active individuals, particularly adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults, are continuing to engage in high-risk sexual behavior. The required statement for oral contraceptives, subdermal implants, injectables, and IUDs is: "This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases." For latex condoms the message reads: "If used properly, latex condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." For female condoms the label reads: "If you are not going to use a male latex condom, you can use a female condom to help protect yourself and your partner." The message on latex condoms will appear on individual condom wrappers as well as on the outer package. Manufacturers will add a similar statement to patient and physician leaflets provided with the products. Other contraceptives that may be relabeled in the future include spermicides, cervical caps, diaphragms, and the contraceptive sponge. The new contraceptive labeling effort is part of a broader initiative of the US Public Health Service regarding women's health that focuses on health issues and diseases in women, including reproductive disorders, breast and other cancers, and substance abuse.
CONTRACEPTION REPORT. 1993 Nov; 4(5):4-7.In May 1993, a Food and Drug Administration (FDA) committee voted to allow women seeking oral contraceptives (OCs) the option of deferring physical examination without denial of the prescription. The ruling came as a result of weighing the risks and benefits of OCs and finding that benefits exceeded the risks. Various opinions were voiced at the committee meeting. Among the reasons for deferral were the apprehension of teenagers who wish to get OCs and the inconvenience of the menstrual period. Planned Parenthood (PP) revised its own medical standards in August 1992 to allow a 3-month deferral based on a nationwide survey done in 1986 that revealed a 60% rate among teenagers who considered the exam a barrier to family planning service use. Data were obtained from 151 teenagers under 18, and 40 teens wished to delay the pelvic exam. The PP-revised standard was endorsed by the American College of Obstetricians and Gynecologists (ACOG). Contraindications to prescribing can be obtained by taking a history, measuring blood pressure, and by a pregnancy test. The most pressing reason for the pelvic exam is to diagnose and treat sexually transmitted diseases. Some were concerned that the change might prompt women not to come back for medical exams and Pap smears. Another element considered was whether deferral of breast examination might also follow, the postponement of which could delay the diagnosis of a malignancy. PP's policy requires women over 30 to have a breast examination prior to receiving an OC prescription. Appropriate counselling and health education is also necessary for women to avoid sexually transmitted diseases and ensure correct use of OCs. However, the follow-up of teenagers may be difficult because of confidentiality. The change of OC labeling and choice of deferral will increase the access of women to safe and effective contraception.
In: Notes from the field in communication for child survival, edited by Renata E. Seidel. Washington, D.C., Academy for Educational Development [AED], Communication and Marketing for Child Survival [HEALTHCOM], 1993 Apr. 189-99. (USAID Contract No. DPE-1018-C-00-5063-00; USAID Contract No. DPE-5984-Z-00-9018-00)Mexico produces and distributes 10 million packets of oral rehydration solution (ORS) annually in its oral rehydration therapy program against diarrheal disease in children under 5 years old. For mothers to seek out, accept, and use the product, however, they must find it appealing, user-friendly, and capable of producing desired health results. Doctors must also provide, recommend, instruct, and reinforce the use of ORS. The product in Mexico long held a scientific-sounding brand name and included misleading instructions on mixing and use. The authors describe the development of a new ORS product name, package design, and graphic mixing/administration instructions which reflect national ORT norms. Consumer research lay at the heart of the project. Research and evaluation consisted of activities in the following phases: exploratory qualitative research with mothers, initial concept screening, quantitative testing of the 2 best designs, quantitative testing of the winning design against the original package, and comprehension testing of mixing instructions and the flyer. Sections consider maintaining a consumer focus; the challenge; getting started; phase 1-5 research; promotion among the primary audience; consensus-building among the secondary audience; reflections; and final thoughts.
[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.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1993 Jul; 14(7):101-6.Many family planning experts are concerned that labeling requirements stipulated by the US Food and Drug Administration (FDA) will create an unfounded bias against the newly approved Reality female condom. Wisconsin Pharmacal Company, the US licensee of Reality, has been directed to include the message that the female condom should be used only if the male condom (claimed to be more protective against sexually transmitted diseases) cannot or will not be used. Also included on all labels, advertising, and promotion must be statistics comparing the pregnancy rates for Reality and other barrier methods. The failure rate the FDA has determined that must be cited for Reality--26%--is considered by many family planning experts to be based on dubious scientific methodology and at least 5% too high. It has been speculated that the FDA's bias against the female condom reflects a lack of confidence in women's ability to use the device correctly. Others have noted that the FDA's handling of the new condom has been based on the issue of user efficacy rather than produce safety. Wisconsin Pharmacal is in the process of distributing Reality condoms for at least half the commercial cost of US $2.50 to public sector clinics that serve women deemed to be at highest risk of human immunodeficiency virus infection.
[Stability of oral rehydration salts in different types of packaging] Estabilidade de sais de reidratacao oral em diferentes tipos de embalagem.
BOLETIN DE LA OFICINA SANITARIA PANAMERICANA. 1993 Oct; 115(4):310-5.This analysis is part of a study coordinated by WHO with the objective of determining the content of water in oral rehydration salt (ORS) packaged in 6 different types of materials and maintained under different conditions of storage, i.e., at ambient temperature, ambient temperature and 76% relative humidity, and at 40 degrees Celsius and 80% relative humidity. The 6 types of packaging materials used were of the following composition: Metalized BOOP 17 gm + milky polyethylene film 22/25 gm; monolucid paper 40 gm + 12 gm of polyethylene + soft aluminum 0.020 gm + 20 gm of polyethylene; 30 gm of Kraft paper + 15 gm of polyethylene + 0.09 gm of soft aluminum + adhesive + 25/30 gm of polyethylene film; 35 gm of cellophane + 25/30 gm of polyethylene; and 18 gm of polyester + 35 gm of aluminum + 50 gm of polyethylene. The formulation of ORS used for this sample was constituted of: 20 gm of glucose anhydride, 3.5 gm of sodium chloride, 2.9 gm of citrate trisodium dihydrate and 1.5 gm of potassium chlorate. A pharmaceutical business prepared the sample in a unique lot and packaged the different types of materials. In the course of 36 weeks, part of these samples were maintained at ambient temperature, the other part at ambient temperature with 76% relative humidity, and the 3rd part at 40 degrees Celsius with 80% relative humidity. The water content was determined using the method of Karl Fischer. In relation to the absorption of humidity, the packaging materials presented different levels of protection to the ORS in the following orders of efficacy: 6 > 2 > 3 > 5 > 1 > 4. The contents of citrate trisodium dehydrate determined by a method described in other works, were within the limits specified by the International Pharmacopoeia, 3rd Edition, with the exception of the content of packaging 4, which in the 36th week exhibited a glucose content less than permitted. Relative to glucose, the samples presented different levels of decomposition in the order of 4 > 1 > 5 > 3 > 2 > 6. The loss of citrate trisodium dihydrate in all packaging of samples was very little between 0.2 and 0.3%.
Achieving self-sufficiency. The Turkey Contraceptive Social Marketing project sold 2.1 million cycles of low-dose pills in 1992.
INTEGRATION. 1993 Sep; (37):32-3.To encourage women in lower socioeconomic groups to realize the benefits of low-dose oral contraceptive (OC) use, the Turkey Contraceptive Social Marketing (CSM) project was initiated in December 1991. Until this time, most Turkish women who used OCs could only obtain high-dose preparations. Many discontinued use because of health concerns, causing the OC market to decline. Working with 3 OC manufacturers, Wyeth, Schering, and Organon CSM is promoting 5 different low-dose OCs with a method-specific educational campaign. Packaging of the OCs contains use instructions written for low-literacy women. Survey results show an increase in OC use in Metropolitan areas from 8 to 12% during 1990-92, with low-dose OCs capturing 61% of the market in 1992 vs. 50% in 1991. With sales at 128% of the first year's objective, the total OC market showed its first increase in years (to 18%). The low-dose OCs have an approval rating of 84%, and 61% of current acceptors are from lower socioeconomic groups. The success of the program was assured by the marketing efforts of the manufacturers, who tripled CSM's efforts. This result has led to plans to include injectables and implants in CSM's marketing efforts, with commercial distribution to being in 1994.
FDA MEDICAL BULLETIN. 1993 Jun; 23(2):4-5.The US Food and Drug Administration (FDA) has notified the manufacturers of oral contraceptives, IUDs implantable and injectable contraceptives, and natural membrane (lambskin) condoms that labeling accompanying their products must state in clear language displayed prominently that they do not provide protection from sexually transmitted diseases (STDs) including AIDS. FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other STDs in sexually active individuals, particularly adolescents and young adults. Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Oral contraceptives, Norplant, Depo Provera, natural membrane (lambskin) condoms, and IUDs are intended to prevent pregnancy and do not protect against HIV infection (AIDS) and other STDs. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. This message is to appear on individual condom wrappers, as well as on the outer package. FDA, is conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom should be changed as well.
PPFA-recommended pill labeling change approved by FDA: physicians may safely defer physical exam. News release.
New York, New York, PPFA, 1993 Aug 18.  p.A package labeling change for the pill has been approved by the US Food and Drug Administration (FDA), which means that American women should have easier access to oral contraceptives (OC) according to Planned Parenthood Federation of America (PPFA). The package insert language advises physicians that they can safely defer a physical examination when prescribing OCs based on a PPFA recommendation. The FDA's action is the result of an advisory from the Fertility and Maternity Health Drugs Committee. The pill with nearly 11 million users is the most popular reversible method of birth control in the US. The FDA-amended labeling for OCs states that the deferred physical examination should include special reference to blood pressure. breasts, abdomen, and pelvic organs. Labeling on approved prescription drugs recommends that clinicians dispense drugs in a particular manner. The FDA previously advised clinicians to perform a physical examination prior to dispensing contraceptives. For women over the age of 30, Planned Parenthood recommends a breast examination, as well, PPFA sought this labeling change because of wide spread concern that fear of pelvic exams was preventing young sexually active women from seeking OCs. A woman also may delay a pelvic examination because she seeks medical care during her menstrual period. Planned Parenthood proposed the labeling change to the FDA and the medical community only after medical studies convinced PPFA to change its own medical standards to allow its clinics to defer the examination. As a result, many Planned Parenthood clinics have routinely and successfully scheduled a pelvic examination any time within the first 90 days on the pill for some time.
AMERICAN JOURNAL OF PUBLIC HEALTH. 1993 Aug; 83(8):1094-9.More is known about the safety of oral contraceptives (OCs) than any other drug. 30 years of OC use show that they are safe. Some reproductive health specialists propose that OCs be available without a prescription. Obtaining a prescription keeps women from using this effective contraceptive because they need to make a costly initial clinic visit, undergo a pelvic examination, and periodic visits or telephone calls for refills, all of which are barriers to OC use. Women themselves can determine their need for OCs. They consider their risk of pregnancy and sexually transmitted diseases (STDs) and the costs and benefits of pregnancy and other contraceptives. Some people argue that OC users are more likely to receive preventive care services, such as STD screening, than are nonusers. Yet, men do not need an annual prescription for condoms to promote early detection of prostate and testicular cancer. This carrot (i.e., coercion) policy assumes that women cannot make their own decisions. Family planning clinics fear losing revenue if OCs were available without a prescription, but family planning providers need to be reimbursed for the primary prevention services they already provide and not for providing prescriptions to OCs. Improper compliance already exists even though women need a prescription to use OCs, so making OCs available over-the-counter will not effect user compliance. Some options to make OCs more accessible include a 28-day format packaging of OCs with comprehensible and legible labels including guidelines on compliance and key danger signals, an initial examination only, elimination of the pelvic examination, and counseling only for first-time users. Over-the-counter options could be a self-administered knowledge inventory maintained by pharmacists, a toll-free telephone authorization process a fax or mail-in order form, over-the-counter purchases for experienced users, and over-the-counter purchase with no restrictions.
BMJ. British Medical Journal. 1993 Apr 3; 306(6882):931.D. R. Bromham and R. S. V. Cartmill report the knowledge and use of secondary contraception among patients requesting termination of pregnancy at a fertility control unit. They found that many patients had switched from using the pill to condoms for contraception, hoping to decrease any risk of contracting AIDS. A considerable number of the women said that a condom had leaked and some that one had split. The authors concluded that an increasing proportion of unplanned pregnancies were due to condom failure. They also found that many women were unaware of the availability of the postcoital pill--popularly and perhaps misleadingly called the morning after pill, although it is recommended for use up to 72 hours after any risk. This exactly reflects my experience in seeing a large number of women who have sought a termination of pregnancy in Liverpool. I wrote to 2 large manufacturers of condoms, pointed out my findings, and suggested that it would be helpful if they included in their product's leaflet information about the postcoital pill, how to obtain it, and in what circumstances to use it. This was in July 1989, and by November I had received considered replies from both manufacturers. One manufacturer wrote: "To incorporate such wording as you suggest within our instructions would imply that the product has a higher failure rate than is actually the case and cast doubt upon the advisability of its use." The other, having said that most "failures" (its inverted commas) are really related to the users and not the product, went on to say: "I find it hard to envisage how such advice could be given without causing potential damage to our own product's reputation." Manufacturers competing in the market may well have a problem, but surely a form of words could be agreed and, with government help, made mandatory for inclusion in all manufacturers' information sheets. (full text)