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Arlington, Virginia, DELIVER, 2014 Jul.  p.This document details two different types of LLIN packaging options -- biodegradable and recyclable -- that can help malaria prevention stakeholders address the challenge presented by the accumulation of LLIN packing waste in communities. It also detailed another option to vastly reduce the amount of material by packaging LLINs in bulk when they will be used in campaigns. All of these options are alternatives to forgoing any special type of packaging. With each option, programs and stakeholders should review the many contextual issues before deciding the best solution for them. Ultimately, any decision that will contribute to a well-managed LLIN packaging waste plan will contribute to an improved malaria prevention program and a reduced risk of contaminating the environment.
AIDS Alert. 2011 Mar; 26(3):33-4.In February of 2011, the Food and Drug Administration (FDA) approved new labeling for the antiretroviral drug atazanavir (Reyataz) to include dosing recommendations for treatment of HIV-1 infection during pregnancy and postpartum period. The major revisions to the package insert are summarized in this report, as well as other minor changes made for consistency.
Recommendations for an educational programme to improve consumer knowledge of and attitudes towards nutritional information on food labels.
SAJCN. South African Journal of Clinical Nutrition. 2001 Feb; 14(1):28-35.The needs and objectives of the various groups affected by nutritional labelling illustrate the complex and controversial nature of nutritional labelling and the problems in formulating a simple and easily understood system. Twenty homogeneous white middle-income suburbs were chosen at random from a total of 39 strata. The multistage cluster method of sampling was used to divide each suburb into smaller clusters. One area was chosen at random from each suburb. Twenty homes were then systematically selected to bring the total sample number of respondents to 400. White middle-income women completed a questionnaire analysing consumer attitudes towards and knowledge of nutritional labelling in order to identify the objectives needed for the formulation of an educational programme concerning the nutritional labelling of food containers. The results of the survey suggest that although white middle-income women (N = 388) lacked nutritional labelling knowledge (pass rate < 20%), they had a positive attitude towards nutritional labelling (mean 18.29 ± 4.8). As knowledge scores increased, the following factors became more positive: attitudes towards nutritional labelling (R = 0.2905, P = 0.0000), nutritional education (c2 = 40.9273, P = 0.01), and the use of nutritional labelling in the purchase of food (r = 0.2230, P = 0.0258). The results of this survey suggest a definite need for a nutritional labelling education programme in South Africa. Although the subject group could be considered representative of the top end of the South African market, a comprehensive needs assessment of the relevant target markets that make up South Africa's diverse population should be undertaken for the formulation of a national nutritional education programme. (author's)
[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.
[Unpublished] 1991 Feb.  p.The summary minutes of the FDA Fertility and Maternal Health Drugs Advisory Committee (2/8/91) focused on improved instructions for taking oral contraceptives (OC). 6 speakers addressed the following items: topic introduction, open hearings with speakers, overview, analysis of current instruction, presentation of new draft OC instruction, justification for changes, manufacturer's instructions, and domestic and international implications. The Committee agreed unanimously with Family Health International (FHI) general recommendations that standardizing and simplifying the OC instructions might increase correct and continued use of this product. The Committee agreed unanimously with FHI's specific recommendation that the patient package insert 1) must be written at 5th and 6th grade reading level with easily understandable words and phrases, 2) must use large print, 3) must display the picture of the pill pack, and 4) must clearly indicate on the pill pack weeks of use: 3 weeks of active and 1 week of inactive pills, the 1st pill, and the directions for pill taking. The Committee unanimously agreed the FHI's specific recommendation for advice on using correct and effective OC as in: 1) taking the pill, 2) when to start the 1st pack of pills, 3) what to do during the month, and what to do if you miss pills, 4) what to do if you miss pills with a start day of Sunday, and 5), with a not on Sunday start day. Discussants represented FHI, International Planned Parenthood, the American College of Obstetrics and Gynecology, and the University Hospital of South Manchester, UK. In the public comments session the speakers who made a presentation represented the Association of Reproductive Health Professionals, Planned Parenthood Federation of America, the National Health Network, Emory School of Medicine, and NIH. A complete transcript is available. Future meeting dates were set.
Seattle, Washington, PATH, 1988. 40 p.The issues of oral rehydration salts (ORS) packet volume and label design must be carefully considered by managers of diarrheal disease control programs. Primary considerations in selecting the volume size are the source of ORS supply and the availability of household containers to measure accurately a predetermined amount of water. The World Health Organization (WHO) stresses the importance of choosing 1 volume to avoid confusion. Although the liter size packet is traditional, few commonly used household containers can be used to measure this amount; another disadvantage is that, since the total volume is not consumed in 1 serving, there is potential for contamination. Some countries have addressed the packet volume problem by distributing standard containers for measuring the water required for a given packet size. ORS label information must cover 3 components: marketing or identification, regulatory information, and mixing and use instructions. The 1st 2 components are intended for physicians and pharmacists, while the 3rd--and most important--is aimed at consumers. Package materials use as part of an oral rehydration treatment program can reinforce campaign themes or complement nonprint channels of communication such as radio messages.
[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.
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.
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.
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.
NETWORK. 1991 Sep; 12(2):14-7, 27.Many unwanted births and pregnancies could be avoided by improving instructions for and comprehension of the use of oral contraceptives. Employed less than only the IUD, the oral contraceptive pill is the 2nd- most widely used reversible form of contraception, used by 8% of all married women of reproductive age. 6-20% of pill users, however, fall pregnant due to improper pill use. Improving instructions in the pill pack, ensuring that instructions are correct, and working to facilitate user understanding and motivation have been identified as priorities in maximizing the overall potential effectiveness of the pill against pregnancy. Since packets in developing countries may consist of pills in cycles of 21, 22, 28, or 35 days, providers must also be trained to instruct users in a manner consistent with the written instructions. Pictorial information should be available especially for semi-literate and illiterate audiences. The essay describes recommendation for instruction standardization and simplification put forth by Family Health International, and endorsed by the U.S. Food and Drug Administration. International Planned Parenthood Federation efforts to increase awareness of this issues are discussed.
Research Triangle Park, North Carolina, FHI, 1991 Feb 8.  p.A special notebook for use at a U.S. Food and Drug Administration meeting held February 8, 1991, for the Advisory Committee on Fertility and Maternal Health Drugs, contains draft instructions for oral contraceptive users to be included in the Patient's Package Insert (PPI). There are 9 manufacturers of 56 types of oral contraceptives in the U.S., as well as 26 family planning organizations, with many different sets of directions for use. Particular discrepancies exist in start date, what to do if 1, 2 or more pills are missed, and in related factors such as the design of the package. The suggested instructions are readable by a person with 5-6th grade reading level, are the same for all pills, and resemble those issued by the IPPF and WHO. THe only exception is the difference between 21- and 28-day pill packages. This draft has been pre-tested on a limited basis on 70 users. The rest of the notebook contains sections on advantages and disadvantages of the proposed instructions, a review of relevant biomedical and social literature on pill-taking with excerpted readings, list of manufacturers, types of instructions by manufacturer, bibliography, and contributors. With a 1st-year failure rate as high as 10%, leading to a 10-year failure rate of 40%, it is assumed that if compliance could be improved, the current estimated 250,000 pill failures annually in the U.S. would decrease.
Washington, D.C., Futures Group, Social Marketing for Change [SOMARC], . ii, 13 p. (USAID Contract No. DPE-3051-Z-00-8043-00)Social marketing, the use of integrated communication strategies to promote specific health products or services, has been successful in the family planning field: this report summarizes effective techniques learned from the family planning experience that may be applicable to social marketing of oral rehydration salts (ORS). Distribution can be facilitated by increasing accessibility, using existing commercial outlets and infrastructure, both traditional and nontraditional, targeting audiences to create demand, and training retailers in proper product use. Pricing is a delicate compromise between consumers' expectations of product quality and adequate compensation for vendors. Product attributes such as taste, mixing instructions and consumer information inserts can improve product desirability. Advertising, product image, branding and promotions should be geared to consumer tastes, on a regional or global basis to reduce development costs. Consumer and retailer promotions will increase visibility for ORS.
[Unpublished] 1991 May. iii, 61 p.This WHO Specifications for Latex Rubber Condoms is appropriate for photocopy as an attachment to the Invitation to Bid and Purchase Order. Section 6 provides a place to indicate size or other specifications. The standard provided is the minimum for use and storage and delivery. Procurement needs to take into account 1) quality of design, and 2) conformance to specifications. Essential criteria are uniform high strength and elasticity and the absence of holes. Chapters include: 1) reason for specification and guidelines, 2) choice of design features, 3) alternative design specifications. The specifications include: 1) scope and definitions, 2) international standards and other publications, 3) requirements for materials, construction, lubrication, tensile properties, freedom from holes, bursting volume and pressure, colorfastness, individual packages, identification marking on individual packages, workmanship, 4) quality assurance provisions for compliance, objective evidence, inspection by purchaser, sampling procedures, examinations and tests for specific properties, inspection of packaging and marking, 5) packaging for delivery (inner boxes, consumer packs, exterior shipping cartons, markings for lot traceability) 6) ordering data. The WHO guidelines for condom procurement reports on 1) testing to insure conformance to specifications, 2) qualifying condom suppliers, 3) invitation to bid, 4) purchase order, 5) predelivery quality check. Additional support documents include: 1) essential performance criteria (limiting condoms that will break during use, that may leak during use, that may deteriorate on the shelf), 2) choosing from available design options (length, width, thickness, shape, lubrication, color, packaging), 3) manufacturers list, 4) invitation to bid, 5) WHO forms: Request for offer and request for sealed bids, 6) purchase order, 7) aggregate analysis criteria for shipments or orders. The recommended condom is parallel sided, reservoir end, 49 2 mm flat width or 53 2 mm flat width, 170 to 180 mm length, .05-.08 mm single wall thickness, smooth surface, no color, translucent, silicone fluid (plain) lubricant, and packaged in square plastic-aluminum foil laminate in 100 units per inner box.
Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?
CONTRACEPTION. 1991 Feb; 43(2):139-47.Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives (OCs) and brand name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, OC packaging is unique to each manufacturer, and any change in brands (and thus in packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons suggested for placing OCs into the critical drug category, where generic substitution and interchangeability of products should not be allowed. (author's)
[Columbia Maryland], Westinghouse Electric Corporation, Public Applied Systems, 1984 Sep. 26,  p. (Contract No. PDC-1406-I-02-4062-00, W.0.2; Project No. 936-5939-12)Westinghouse Health Systems, under a US Agency for International Development (USAID) contract, ass ssed the global supply and demand of oral rehydration salts (ORS) and developed a set of recommendations concerning USAID's future role as a supplier of ORS. 1.5 billion ORS packets (assuming each packet is equivalent to 1 liter of ORS solution) would be required to treat all ORS treatable cases of diarrhea which occur annually among the world's children under 5 years of age. Currently, about 200 million packets are manufactured/year. In 1983, international sources supplied slightly less than 37 million packets, and the remaining packets were produced by local or in-country manufacturers. UN Children's Fund (UNICEF), which currently provides 81% of the international supply, contracts with private firms to manufacture ORS and then distributes the packets to developing countries, either at cost or free of charge. UNICEF purchases the packets for about US$.04-US$.05. USAID provides about 12.3% of the international supply. Prior to 1981, USAID distributed UNICEF packets. Since 1981, USAID has distributed ORS packets manufactured by the US firm of Jianas Brothers. USAID must pay a relatively high price for the packets (US$.08-US$.09) since the manufacturer is required to produce the packets on an as needed basis. Other international suppliers of ORS include the International Dispensary Association, the Swedish International Development Authority, the International Red Cross, and the World Health Organization. Currently, 38 developing countries manufacture and distrubute their own ORS products. These findings indicate that there is a need to increase the supply of ORS; however, the supply and demand in the future is unpredictable. Factors which may alter the supply and demand in the future include 1) the development of superior alternative formulations and different type of ORS products, 2) a reduction in the incidence of diarrhea due to improved environmental conditions or the development of a vaccine for diarrhea, 3) increased production of ORS in developing countries, 4) increased commercial sector involvement in the production and sale of ORS products, and 5) the use of more effective marketing techniques and more efficient distribution systems for ORS products. USAID options as a future supplier of ORS include 1) purchasing and distributing UNICEF packets; 2) contracting with a US firm to develop a central procurement system, similar to USAID's current contraceptive procurement system; 3) contracting with the a US firm to establish a ORS stockpile of a specified amount; 4) promoting private and public sector production of ORS within developing countries; 5) including ORS as 1 of the commodities available to all USAID assisted countries. The investigators recommended that USAID should contribute toward increasing the global supply of ORS; however, given the unpredictability of the ORS demand and supply, USAID should adopt a short-term and flexible strategy. This strategy precludes the establishment of a central procurement system; instead, USAID should contract a private firm to establish an ORS stockpile and to fill orders from the stockpile. Consideration should be given to altering the ORS packets size and to alternative ORS presentations. USAID should also promote the production of quality ORS products within developing countries and continue to support research on other diarrhea intervention strategies. This report also discusses some of the problems involved in manufacturing and packaging ORS. The appendices contain 1) a WHO and UNICEF statement on the ORS formulation made with citrate instead of bicarbonate, 2) a list of developing countries which manufacture ORS, and 3) statistical information on distribution of ORS by international sources.
Trip report: Honduras Contraceptive Social Marketing Program, Tegucigalpa, Honduras, June 11 - June 18, 1984.
Washington, D.C., Futures Group, International Contraceptive Social Marketing Progam, 1984. 25 p. (Project No. AID/DSPE-CA-0087)At the request of the International Contraceptive Social Marketing Project, Tennyson Levy of the Tritora Corporation visited Honduras in June, 1984, to assist the Honduras Contraceptive Social Marketing Project to conduct market research to assess the impact of a 5-week advertising program. The campaign was undertaken to launch the introduction of the program's 1st product, Perla, a standard dose oral contraceptive (OC). During the visit the consultant was asked to assist in the development of an advertising plan for all 4 products which will be distributed by the program. The other 3 products are 1) Prebien, a low dose OC; 2) Guardian, a condom; and 3) Sana, a vaginal tablet. The consultant also helped develop research to guide the development of appropriate packages for the Guardian and Sana products. The distribution of Perla began in March, 1984, and the media campaign was conducted during May, 1984. Monthly sales for March amounted to 5271 cycles, and for May, 11,256 cycles. The campaign consisted of 2 45-second radio spots which ran 30 times a day for a month and a press ad. A visit to 12 pharmacies in June to obtain feedback about the advertising campaign led to the conclusion that the campaign increased awareness of Perla, of how it could be obtained, and of how much it cost; however, the campaign did little to alter women's fears and misconceptions about OCs. Recommendations were made for conducting a 2-phase advertising campaign to further promote Perla. The 1st phase will begin immediately and run for 8 weeks. The objective of the 1st phase will be to address women's fears and misconceptions about OCs. The 2nd phase will run from September 1984-July 1985, and the objectives of this phase will be to promote Perla as a method to avoid pregnancies which might keep women from attaining their personal goals, to encourage married women to use Perla to space their births and to limit family size, and to protect unmarried women from the fear of an unwanted pregnancy. Specific messages and channels for disseminating the messages for each phase of the campaign were specified. Communication strategies for the other 3 products were also provided. Guardian messages will seek to equate the macho image with responsible behavior. The Prebien campaign will be directed toward 16-24 year olds, and the Sana compaign will stress that vaginal tablets are a convenient method for lactating women, for teenagers, and for women who engage in sexual activities infrequently. A research strategy for conducting market research throughout the 13-month advertising campaign was developed. A previously developed survey questionnaire for evaluating the advertising campaign was redrafted, and an appropriate sampling strategy for the survey was developed. Pertinent research topics were identified, and a research time table was proposed. An advertising budget was also developed. Funds currently available for the campaign (US$93,000) are inadequate, and additional funds must be requested. The radio spots used in the initial Perla campaign are included in the appendix.
In: Proceedings of the International Conference on Oral Rehydration Therapy, June 7-10, 1983, Washington, D.C., edited by Richard Cash. Washington, D.C., Agency for International Development [AID], Bureau for Science and Technology, 1983. 159-62. (International Conference on Oral Rehydration Therapy, 1983, proceedings)Diarrheal diseases and associated states of malnutrition account for the deaths of 5 million children under 5 years of age every year. Oral Rehydration Therapy (ORT) is a proven tool in dealing with this problem. The best approach to ORT should be decided according to local circumstances. Home prepared solutions (ORS) may be introduced either as a sugar/salt type of solution or a food based solution such as rice water. Availability of these ingredients at an affordable price would be required. Investment of time on the part of health educators would also be required. Prepackaged ORS is perceived as providing greater efficacy and is considered preferable. The problem of logistics is greater, however, and the following requirements must be met: 1) an estimation must be made of the quantities of ORS packets required in the area; 2) packaging may be done at a a cottage industry level or centrally on a national or regional scale, or packets may be imported; 3) supplies must be distributed efficiently to the user. Options include: 1) fully commercial channels, 2) semicommercial channels or social markets, or 3) the health services. Continuous restocking will need to be pushed through the system. Additionally, at least 2 other areas need to be dealt with: 1) promotion and public education concerning ORT and 2) research both in terms of developing the formula into super ORS using amino acids and in terms of social anthropology.
[Unpublished] 1984. i, 17 p.On March 8, 1984, a group of experts was assembled by the American Public Health Association (APHA) to discuss oral contraceptive (OC) needs of developing countries. The group reviewed current information on OC clinical trial performance, lipid effects, potency/dosage issues, relationship to female reproductive cancers, specific developing country concerns, and various programmatic issues. Particular concern was voiced about the need to try to avoid OC formulation switching in developing country programs since this can have significant adverse effects. Because of logistical difficulties, many developing country programs have difficulty suppling more than 1 OC. Recommendations for minimizing this continuity problem include: 1) providing a single predominant OC for most developing country programs; 2) engaging in multiple-year procurements; and 3) attempting to continue to provide a particular formulation in special circumstances where it has a high proprietary and/or continuity value, (e.g., social marketing programs). Some 30-35 ug estrogen OCs currently available in the US appear to perform in clinical trials at roughly the same general acceptable level as the 50 ug estrogen OCs. Accordingly, there was a general consensus among the group that a single predominant pill should be selected from among these particular 30-35 ug estrogen OCs. At the same time, it was clearly not the group's intent to recommend limiting OCs provided to developing countries to this particular set. Based on concern about human variability, contraceptive efficacy, program continuity, and the desires of developing countries themselves, another list of formulations was also considered suitable. (author's modified)
[Unpublished] 1978. 26 p.The 4 marketing variables of product concerns, pricing, distribution and promotion, as well as planning and finance, transition from Westinghouse toNepali management, and areas needing improvement are discussed for a commercial distribution of contraceptives project in Nepal. The selection process for brand names for project pills and condoms indicated the effort expended in adapting the products for Nepali conditions. Packaging opportunities discussed by the consultants include possible need for introduction of the low-dose pill and addition of "piggy-backed" vitamins with the pills. It was recommended that consumer demand be generated for existing distrigution outlets before new outlets and marketing areas are sought, that th bond requirement for dealers stocking the contraceptives be dropped, and that adequate storage space be sought. Serious problems were found in project advertising in both content and media mix; suggestions for improvement included increased local promotion, market research and sampling of products, and production of a promotional movie. 3 organizations were identified which might be capable of absorbing the project after termination of activities by the present contractor.
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.
Report prepared during the period April 11 through May 10, 1976, under the auspices of the American Public Health Association, in agreement with the U.S. Agency for International Development. 9 p. (Authorization: AID/pha/C-1100 Ltr. POP/FPS 2/11/76) (APHA Assgn. No.: 1100-031)Summary of observations and recommendations from consultations to assist an Indonesian marketing program and advise on design of a pilot promotion campaign in rural Thailand. The Indonesian program distributed condoms through commercial outlets distributing an indigenous herbal medicine, and was initiated by Yayasan Indonesia Sejaktera (YIS). Sales were lower than anticipated, but there was only modest allocation for promotion. The program met with notable success given the constraints of the existing marketing system, which is almost wholly passive, relying on consumer demand, and the limited staffing and budgetary resources available to YIS. As originally designed the program was too ambitious, and it was recommended that it be continued in a different format. Preconditions that would have to be met included change to an experimental marketing program rather than a commercial distribution project, inclusion of oral contraceptives, and change to an urban setting. Specific recommendations on establishing the project, stimulation of demand, staffing, research backup, feedback mechanisms, pricing, direct selling, repackaging, establishing a brand name, and point of purchase promotion, are offered. The Thai program was at the implementation stage, research on attitudes toward condoms among rural Thai residents and clinic personnel having been completed, and a media promotion designed on the basis of the findings. The consultant met with program personnel and recommended arrangements for implementation. His chief concern was that funds would not be sufficient or not enough time would be allowed to obtain meaningful results.
Washington Post. 1969 Dec 22; A1, A10.Dr. Herbert L. Ley, Jr., until three weeks ago, Food and Drug Administration Commissioner, said yesterday the government must consider action to see that the 8.5 million American women taking birth control pills get "much greater information" on their possible ill effects. This could mean giving women several hundreds of words of information on how the pill may cause blood clots, strokes and skin discoloration, and how they may be involved in liver, thyroid, urinary and vaginal problems; changes in pituitary, ovarian and other hormone functions; eye trouble; depression and suicidal urges. He said: "Speaking as a private citizen and as a concerned physician, I feel a need for greater information for the patient. Also, Ley said, his new feeling "is the crystallization of some thinking for a long period of time" about "the whole category of drugs to prevent something, given to healthy people" compounds like birth control pills, anticholesterol drugs and preventive vaccines, all of which sometimes have undesirable effects". "I think the patient has to be involved and involved very deeply in information on this new category of drugs. I think he needs to be involved in the decision on when to use them". Here, he said, he has been impressed by some arguments in a recent book, "The Doctors' Case Against the Pill" by Barbara Seaman, and its case for a patients' package insert explaining the pill's advantages and disadvantages. An announcement by Sen. Gaylord Nelson (D-Wis.) said that on Jan. 14 his Senate Monopoly Subcommittee will begin hearings to learn whether women "are being adequately informed of the pills' known hazards". "It appears evident," Nelson charges, "that a substantial number are not advised of any of the health hazards or side effects". For his part, Ley said he still stands by the September finding of an FDA advisory committee that the pill is "safe" as defined by law, and that the pills' "significant" benefits outweigh their risks. "That was a highly dependable report", he said yesterday, but "it's dated, as any report is", and "we absolutely have to look now at any new British data. Until I see hard data, however, I'm hard pressed to draw different conclusions. I may wish to revise my opinion as a private physician after I see the British data but not until".(AUTHOR'S MODIFIED)