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  1. 1

    Field experience with ORT production.

    Faust H

    In: Proceedings of the International Conference on Oral Rehydration Therapy, June 7-10, 1983, Washington, D.C., edited by Richard Cash. Washington, D.C., AID, International Center for Diarrhoeal Disease Research, Bangladesh [ICDDR/B], United Nations Children's Fund [UNICEF], and the World Health Organization [WHO], 1983. 156-9. (International Conference on Oral Rehydration Therapy, 1983, proceedings)

    In 1969 the World Health Organization (WHO) arranged for trials of oral rehydration salts (ORS) production. The formula that was developed contained the following basic ingredients per liter of water: 20.0 grams of glucose anhydrous, 3.5 grams of sodium chloride, 2.5 grams of sodium bicarbonate and 1.5 grams of potassium chloride. As the product has become more widely used, a problem with its stability has been discovered, due to the interaction of glucose and sodium hydrogen carbonate. The stability problem was solved in some developing countries by packing glucose or bicarbonate separately, but the solution was not feasible in some countries due to a lack of necessary facilities or funds to maintain them. Based on WHO initiated testing, trisodium citrate offered the best prospects as a substitute for bicarbonate. It should be noted that the present ORS formulation is not discredited by the citrate alteration. If the bicarbonate formula is to be produced it should be packaged in a number of ways including aluminum foil, polyethylene bags, or 2 separate bags, depending upon where or when they will be distributed. The citrate formula should be packaged in aluminum foil, polyethylene bags, or paper/polyethylene laminations, depending upon use. Choice of formula and packing material depends also on the quantity to be produced. Small amounts of ORS can be prepared in hospital pharmacies for in and outpatients. Quantities of more than 2 million packets per year are easier to fill with semiautomatic equipment. Quantities of 4 million or more are more conveniently filled with an automatic machine. In most cases locally produced ORS is no less expensive than imported packets, but they offer advantages like the ability to respond immediately in an emergency and freedom to choose a dosage that is adapted to a standard size container for the country. Flexibility to produce ORS according to local needs and the principle of self reliance are also important advantages of locally produced ORS.
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  2. 2

    ORS in the context of the essential drug program.

    Goodall R

    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.
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  3. 3
    Peer Reviewed

    The patient's understanding of the oral contraceptive patient package insert.

    Casey FG; Fluitt DM; Wiatt AL

    Military Medicine. 1983 Mar; 148(3):276-8.

    A study was conducted in a 60-bed military hospital in Fort Eustis, Virginia to determine the following: do women read the oral contraceptive (OC) patient package insert; what is the ability of women to actively recall information concerning proper use of OCs; and is there a difference in the level of understanding of OCs perceived by women and the actual proper instructions which should be followed. Outpatients receiving OCs are provided a 90-day supply from the pharmacy. The study was conducted for 1 calendar month. All women presenting new or refill requests for OCs at the outpatient section of pharmacy services were eligible for inclusion in the study. It is an outpatient pharmacy dispensing policy to require a new prescription after 3 refills or 12 months after the date of issue for OCs. Only 21-day packs are stocked; therefore, all patients' regimens consist of the 3 weeks on and 1 week off dosing schedule. The data for the study were obtained through the use of a patient questionnaire. The patients completed the questionnaire in the prescription waiting area of the outpatient clinic. Upon receipt of the OC prescription, the patient returned the completed questionnaire to the pharmacist. Only 57% of the study population of 81 could recall the name of their OC. Of the 81 patients surveyed, 89% stated that they had read the patient package insert which was included with their 1st pill pack, but only 31% said they read it each time they received a new pack. 25% said that they did not fully understand the package insert. 35% responded that they would seek additional explanations from health professionals, primarily the physician (21%). 73% of the patients indicated that they took their pill at the same time daily, while 27% indicated that they did not. This is of no partilar significance, but it is felt that a uniform dosage regimen will establish a routine which would reduce the risk of error. 70% of the study population had, at some time, forgotten to take a pill. 88% knew the correct step to take if they only missed 1 pill. If 2 pills were missed, only 16% knew the correct method to catch up. 26% knew to stop their pack if 3 pills were missed. 38% knew to continue their pills as usual in the absence of 1 menstrual period. 86% were correct in suspecting pregnancy and seeing their physician with the absence of 2 periods. 15% of the study population felt incorrectly that they needed additional birth control measures between pill packs. In sum, it should not be taken for granted that the OC patient understands how to properly take her pills. The pharmacist can clarify and reinforce physician instructions.
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  4. 4

    Official transcript of proceedings; Food and Drug Administration. Depo-Provera Public Board of Inquiry. Vol. 1, January 10, 1983.

    United States. Food and Drug Administration [FDA]. Depo-Provera Public Board of Inquiry

    Arlington, Virginia, TIW Reporting Group, [1983]. 205 p.

    The objective of the Depo-Provera Public Board of Inquiry is to determine how the conclusion reached on the basis of data and facts presented can be interpreted in light of that evidence. Both "pro and con views" are questioned. These proceedings include the opening remarks of Doctor Judith Weisz and presentations and comments from the following physicians: Jacob C Stucki; Gordon W. Duncan; Roy Hertz; Marion Valerio; Ron H. Gray; Saul Ginsberg; George L. Wied; J.C. Stryker; Elizabeth B. Connell; Daniel R. Misbell Jr.; Robert Carlson; and Dr. Assenzo. In his testimony Dr. Stucki, Vice President of Pharmaceutical Research, Upjohn, presented slides demonstrating a chronology of research regulatory events concerning Depo-Provera. Stucki reported that 25 years of research has generated an enormous body of literature on Depo-Provera and numerous submissions to the US Food and Drug Administration (FDA). With each challenge to Depo-Provera, the information and any new findings were reexamined. According to Stucki, each reevaluation has added to the evidence of Depo-Provera's safety. Stucki related that the Board of Inquiry addresses 7 questions each focusing in 1 way or another on Depo-Provera's safety as a contraceptive. 2 questions relate to the issue of whether it is reasonable to extrapolate from the animal data to humans in predicting cancer risk, and whether there are sufficient data from human use to make a judgment. Several witnesses discuss the extensive data relating to this issue. According to Stucki, the witnesses share the conviction that there is strong scientific basis for the conclusion that tumors found in some animals are not predictive of a risk of cancer in humans and that evidence from the use of Depo-Provera in thousands of women over a 20-year period support the conclusion that Depo-Provera does not increase the risk of cancer in women. In a 3rd question, the FDA asks if Depo-Provera is likely to cause birth defects if it is inadvertently taken during pregnancy. Stucki relates that witnesses for the Upjohn Company show that there is no evidence that Depo-Provera increases the risk of such defects. Another critical issue is whether the risks of Depo-Provera outweigh its benefits. A question about supplemental estrogen use is addressed by a brief presentation of evidence that this has not been and will not be a problem in clinical use of Depo-Provera. Stucki states that 2 questions appear to go beyond the scope of scientific inquiry: whether Depo-Provera under general marketing conditions is likely to increase out of label use; and whether labeling and distribution controls should be imposed to permit only limited marketing.
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  5. 5

    A model for market research in contraceptive social marketing.

    Greenberg R; Novelli WD; Curtin L

    Washington, D.C., Futures Group, 1983 Feb 14. 130 p.

    The process model developed in this paper for marketing analysis, planning, implementation, and control of contraceptive social marketing (CSM) programs is circular, with the last stage feeding back into the 1st. In the 1st stage, analysis, it is necessary to examine the market, the consumers, and the organization and structure within which the CSM program must operate. This includes geographical factors, distribution and sales outlets, local resources, behavioral factors, user status, media patterns, and staff resources. The 2nd stage, planning, involves setting marketing program objectives, market target segmentation, marketing mix strategies, identifying the media that will be used and establishing interpersonal contacts. The 3rd stage involves the development, testing, and refinement of plan elements. This involves the concepts and components of the products, distribution, pricing, concept and message communication, and program testing and training. Product tests concentrate on names, packaging, and logo. In the 4th stage, implementation, the full program is put into effect, requiring the implementing of the plan of action prepared in stage 2, monitoring marketing progress, and monitoring the institutional/structural performance of the CSM organization. As part of this step the communication elements of advertising, publicizing, and promotion must be activated. The 5th stage, in-market effectiveness assessment, can tell if the program is meeting its goals, any corrections which need to be made, and how the next cycle should be planned. At the 6th stage the monitoring and assessment is fed back into stage 1 to identify problems and revise the procedure. The author discusses the uses the methods of primary and secondary marketing research as well as qualitative and quantitative market research methods. The following types of research should be given priority: 1) research that will fill serious information gaps, 2) research that is most likely to be applied for marketing decision-making, 3) research that will reduce the risk of uncertainty associated with making major program changes, and 4) research that provides essential, periodic indicators of market response to ongoing program activities.
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  6. 6

    International standardization of mechanical contraceptives.

    Mellstam S

    IPPF Medical Bulletin. 1983 Jun; 17(3):2-4.

    At least 12 countries have regulations for condoms, and because of the complicated regulations relating to condoms the International Organization for Standardization (ISO) was asked to create a committee for contraceptives. Its objective is to promote the development of standards throughout the world to help the international exchange of goods and services. Following discussions between the World Health Organization (WHO) and ISO it was decided in 1974 to establish a technical ISO committee that would deal with international standards for mechanical contraceptives, comprising condoms, diaphragms, and IUDs. It was also decided that spermicides and oral contraceptives (OCs) should be excluded from the ISO effort, but that they should fall within the responsibility of WHO. The committee, entitled ISO/TC 157 Mechanical Contraceptives, was represented by 35 member countries in 1982. The object of standardizing condoms is to obtain a satisfactory quality that can be accepted throughout the world. To achieve that purpose, acceptable test methods and associated limit requirements and values must be determined, along with rules for storage, packaging, and labeling. The most important factors in determining condom quality are the need to reach agreement on an acceptable number of holes in the condom and the ability to establish limit values for the mechanical properties of the condom. Specific requirements regarding dimensions, resistance to storage, packaging, labeling, and appropriate storage are also important. Up to 1982 the work of ISO for condoms resulted in 8 published international standards, of which 6 deal with test methods, 1 with packaging and labeling, and 1 with storage. Agreement has also been reached within the ISO committee on an additional 3 draft standards. Due to the comparatively small use of diaphragms, standardization efforts in this area do not have the highest priority. ISO/TC 157 has formulated 10 drafts which are being prepared for distribution to the ISO member countries for purposes of voting. 7 of these standards deal with test methods, 1 with sampling and requirements, 1 makes storage recommendations, and 1 refers to packaging and labeling. A working group for standardizing IUDs was established in 1976. It was agreed within ISO/TC 157 after almost 3 years to publish a Technical Report (TR 7439) for IUDs. The report deals with such things as the definition of IUDs, general requirements for type approval, batch inspection, storage recommendations, and packaging and labeling. The report shall constitute the basis for continued standardization efforts for IUDs.
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  7. 7

    Food and Drug Administration approves vaginal sponge.

    Kafka D; Gold RB

    Family Planning Perspectives. 1983 May-Jun; 15(3):146-8.

    On April 1, 1983, the US Food and Drug Administration (FDA) approved a disposable vaginal sponge of soft polyurethane foam saturated with 1 gm of nonoxynol-9 as a nonprescription contraceptive offering 2 improvements over products already available: ability to leave in place up to 24 hours, and no need for additional application of spermicide for repeated acts of intercourse. Clinical tests show the sponge to be comparable in effectiveness to other vaginal methods including the diaphragm. Although no major medical complications have been detected in studies of the sponge thus far, concern over the possibility of its causing toxic shock syndrome led the FDA to require package labeling recommending that the product not be used during menstruation. The sponge was developed by the V.L.I. Corporation of California and will be marketed for about $1 under the brand name "Today." The sponge must be moistened with water before insertion to activate the spermicide, and is believed to prevent conception by releasing the spermicide over 24 hours, blocking the cervix to some extent, and absorbing sperm. The sponge has undergone 5 years of clinical testing in the US and abroad and is the 1st nonprescription contraceptive to go through the safety and efficacy tests required for prescription drugs and devices. Controlled, comparative tests conducted by the International Fertility Research Program began in 1979 in volunteers aged 18-40 who were randomly assigned to the sponge or another vaginal method. Available results are based on 1582 sponge users and 1579 controls. The data reviewed by the FDA advisory committee were based on 720 sponge users and a similar number of diaphragm users in the US segment. The 12-month pregnancy rates from the US trials were 15.8/100 women for the sponge and 11.6/100 women with the diaphragm, not a statistically significant difference. The US data suggest that about 4% of users will develop allergic reactions such as itching, irritation, and rash.
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  8. 8

    Infant and young child nutrition, including the nutritional value and safety of products specifically intended for infant and young child feeding and the status of compliance with and implementation of the International Code of Marketing of Breast-milk Substitutes: report by the Director-General.

    World Health Organization [WHO]

    Geneva, Switzerland, WHO, March 1983. 39 p.

    This report to the Health Assembly is presented in 3 parts: Part I--a summary of the present global nutritional situation with particular reference to infants and young children--is based on an initial reading of the results of national surveillance and monitoring activities in over 50 countries. Part II has been prepared in accordance with resolution WHA34.23 which requested the Director-General to report to the Assembly on steps taken to assess the changes that occur with time and under various climatic conditions in the quality, nutritional value and safety of products specifically intended for infant and young child feeding. Part III, in accordance with resolution WHA34.22, summarizes information provided by Member States on action being taken to give effect to the International Code of Marketing of Breast-milk Substitutes. It should be read in conjunction with section VI of the Director-General's progress report which informed the 35th World Health Assembly of action taken by WHO and its Member States in the field of infant and young child feeding. In light of the information on the implementation of the Code contained in these 2 reports, and in the absence of any suggestions from Member States for change, the Director-General considers that it would be premature, at this time, to propose any revision of the text of the Code, either its form or content. The Health Assembly's attention will be drawn, in future biennial progress reports on infant and young child feeding, to any development which may have a bearing on the International Code, in accordance with its Article 11.7 and resolution WHA33.32.
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  9. 9

    Study on packaging, logos, names, and colors of contraceptives in Haiti.

    Lataillade E

    Washington, D.C., Futures Group, [1983]. 72 p. (Project No. AID/DSPC-CA-0087)

    This study of commercialization of contraceptives in Port-au-Prince, Haiti was conducted to generate information about packaging design, logos, names, colors, and prices that could influence potential users to buy contraceptives and to determine factors related to uses of methods that could influence their choices. Specific study objectives were as follows: determining certain characteristics of the market such as incidence of contraceptive use and user's age and socioeconomic class; determining the list of benefits sought by users and potential users of contraceptives, the ideal contraceptive, usage information, and incidence of selling price; identifying certain factors, i.e., needs, desires, opinions of present services; and determining preference for brand name, packaging design, logos, and colors of contraceptives. A total of 300 interviews were conducted--100 women for the oral contraceptives (OCs), 100 women for the foaming tablets, and 100 men for the condoms. The following were among the study findings: in general, all respondents were aware of 1 contraceptive method; from 100 interviewed, 82% knew about OCs, and 85% of the 82 were past users; 71% of the present OC users (49) purchased their pills at a pharmacy, and 21% preferred the Ortho Novum brand; 24% of the 82 ever users would prefer 2 cycles in a package, and the same percentage preferred more than 3 cycles; among the 100 interviewed regarding the condom, 68% were past users of a contraceptive method from which 74% (50) were condom users, and 69% were presently using the condom; in general, reasons given for using condoms were mainly easy availability, no side effects, no medical visit, and disease prevention; the benefits sought from the ideal condom were thin, resistant, inexpensive, and available by unit; among the 69% current condom users, 29 buy them in a pharmacy or small shop and most of them asked for Tahiti brand; respondents said they are willing to pay anything less than US$1 for good quality condoms (they indicated that Tahiti was "not good quality"); 70% of those interviewed about foaming tablets knew about this method, but only 20 respondents were past users of the tablets and 35 were actual users; most foam tablet dropouts considered the method inefficient; reasons given by respondents for having chosen foaming tablets were recommended by relative or friends and do not require daily utilization; and 66% of foaming tablet users bought their products in a pharmacy.
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  10. 10

    Today vaginal contraceptive sponge: a technical review.

    Vorhauer BW; Edelman DA; North B; Soderstrom RM

    Irvine, California, VLI Corporation, Professional Relations Department, 1983 Jun. 9 p.

    A new vaginal contraceptive sponge (Today) successfully completed the US Food and Drug Administration NEW DRUG review process for safety and efficacy on April 1, 1983. The Today sponge will be marketed as an over-the-counter drug. The product consists of a resilient, hydrophilic, polyurethane foam sponge impregnated during manufacture with nonoxynol-9 (N-9), a spermicide in use worldwide for over 20 years. N-9 has been classified as safe and effective by the FDA Advisory Review Panel on OTC Vaginal Contraceptives. Contraception with the Today sponge occurs by: 1) spermicidal action of N-9, 2) sperm absorption into the sponge, and 3) blockage of the cervix. The principal advantage of the Today contraceptive sponge, aside from being available without prescription, is that it separates the act of contraception from that of intercourse, thus permitting for the 1st time, sexual spontaneity with a vaginal contraceptive. Multiple coital episodes are possible with a single sponge. Preclinical USP toxicity studies, mutagenicity assays, allergenic response tests, microbiological studies, and human clinical trials conclusively show no evidence of a significant health risk. The product was found in laboratory tests to be hostile to the growth of Staphylococcus aureas, suspected in the etiology of Toxic Shock Syndrome (TSS). Clinical trials with the Today contraceptive sponge, however, were not large enough to assess the risk of developing TSS. Particular attention has been directed to demonstrating safety with respect to carcinogenicity and mutagenicity. Assays for monomers have continually shown the finished product sponge and the polymeric sponge alone to lack any concerns in this area. These assays are conducted on a continuing basis through a formal stability program now in its 3rd year. This stability program includes accelerated testing at both high and low temperatures for up to 3 months, which has confirmed a lack of product degradation. Further, and most significantly, the product has been subjected to a stringent series of carcinogenicity and mutagenicity screens consisting of both the Ames Salmonella Mutagenicity Test and the Mouse Lymphoma Forward Mutation Assay. These tests have been conducted by both Huntingdon Research Center and Litton Bionetics, and have been successfully passed by the Today sponge in every instance. Phase I trials beginning in 1977 (100 women) demonstrated general acceptability and led to improvements in contraceptive capability. Phase 2 clinical trials beginning in 1978 (400 women) produced a cumulative 6-month life-table pregnancy rate of 5.98/100 women; the protocol called for 1 month use of a single sponge with reuse/washing permitted for a maximum of 10 washings. Phase 3 randomized comparative trials (1600 women) began in 1979 and are ongoing internationally and in the US. This protocol calls for a single sponge use for up to 48 hours wear time. Data to date indicate that sponge effectiveness is in the same range as other vaginal contraceptives. Analysis of the outcome of pregnancies during and after use of the sponge indicates no teratologic or embryologic effects. Of the 719 women in the US studies, 1.7% discontinued because of itching, irritation, rash; 1.9% discontinued because of allergic reactions. These results are consistent with the normal allergenic reactions experienced with the use of N-9. Since insufficient numbers of women in the Phase 3 studies chose to use the sponge for a full 48 hour period, statistical analysis of effectiveness data permits only a single day use recommendation. Thus, in the US, users are instructed to rely on the sponge for pregnancy prevention no longer than 24 hours and to leave the sponge in place at least 6 hours after the last episode of coitus. (author's modified)
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  11. 11

    VLI's contraceptive sponge: toxic shock warning urged by consumerist group.

    Fdc Reports. Drugs and Cosmetics. 1983 Jun 20; 45(25):T and G-10.

    In a recent petition to FDA, Empire State Consumer Association President Judy Braiman-Lipson, referring to FDA's regulation that tampon packages warn women of the potential risk of toxic shock syndrome (TSS), declared: "If this contraceptive is being promoted by the manufacturer to be worn during menstruation, then the same TSS warning should be on the box or inside literature of this sponge." Braiman-Lipson supported her argument for more stringent toxic shock alerts on Today vaginal 24-hour sponges by saying that, like the sponge, Rely tampons contained polyurethane. Rely tampons were removed from the market by Proctor and Gamble when it appeared the device contributed to increased occurrence of TSS. The consumer advocate added that the contraceptive sponge "will soak up material that can serve as a culture medium" for bacteria. When VLI's Today sponge containing nonoxynol-9 was approved by FDA in April, FDA's Office of New Drug Evaluation Acting Director Robert Temple, MD, recommended that information booklets distributed with the product include a statement that "clinical trials with the Today vaginal contraceptive sponge were not large enough to assess the risk of developing the TSS" ("The Pink Sheet" April 11, p.11). During the October 27 meeting of the FDA Fertility Advisory Committee, VLI President Bruce Vorhauer, PhD, noted that the company has made "no claim that we have not had...cases of toxic shock." He added, however, that in laboratory tests at USC, where sponges were inoculated with various bacteria, "the sponge did not support the growth of any of these bacteria" ("The Pink Sheet" November 1, T and G-9). Braiman-Lipson also requested that FDA comment on 2 studies. 1, published by N.I. Volfson in 1979, shows a "high frequency of precancerous and cancerous lesions in mice which received daily insertions of polyurethane sponge tampons," Braiman-Lipson said. And a 1982 study published by C. Lawrence Slade, et al, concludes: "Polyurethane implanted to date have slowly disintegrated and have been absorbed in tissue." (full text)
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  12. 12

    Educating the public about oral rehydration therapy.

    Smith WA

    [Unpublished] 1983. Presented at the International Conference on Oral Rehydration Therapy, June 7-10, 1983, Washington, D.C. 8 p.

    The medical community has shifted its concern from the clinical efficacy of oral rehydration therapy (ORT) towards the practical risks of using ORT in unsupervised settings. The latter can result in dangerously superconcentrated OR salts, ineffective diluted solutions, too rapid administraion, or administration given alone for long periods. Programs exist in Honduras and the Gambia to re-educate the public about ORT. The goal of these programs is to have mothers use ORT early in an episode of diarrhea and to seek help if needed. Early results of evaluations of these programs indicate: 1) after 1 year in Honduras, 48% of the audience reported using Litrosol to treat diarrhea at least once; 2) during that year recognition of Litrosol as a remedy for diarrhea went from 0-93% of the population; and 3) in the Gambia, after 8 months of education, 66% of mothers knew the correct formula and 47% reported using the correct formula to treat their child's diarrhea. In order to produce widespread ORT use in unsupervised settings, it is necessary to reach many people quickly, probably using the media which in most countries means radio, as well as to provide the mixing information where is is needed, such as on the packet label, and to gain credibility. To bring these elements together, a plan must include an adequate supply and distribution system for OR salts, a training program for health providers, print materials, and fixed radio schedules timed to reach specific audiences. Such a program must rise above the everyday clutter of advice and suggestions to become an important new priority in the people's lives and requires a sensitive understanding of how people are affected by specific health problems, articulate wording of messages, and a coordinated distribution network.
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  13. 13

    New packaging specifications prompt OC shelf life study.

    Program for the Introduction and Adaptation of Contraceptive Technology [PIACT]

    Piact Product News. 1983 Dec; 5(1):4.

    when a major donor of contraceptives changed the packaging specifications of norethindrone/mestranol oral contraceptives (OCs), the change raised some questions as to product shelf life. The new specifications called for the OCs to be packaged in bulk with 100 blister packs/aluminum/plastic overpack. These revised packaging specifications would lead to removal of the blister pack from the protective overpack at an earlier point in the supply chain, and therefore to earlier potential exposure to high temperatures and humidity. However, stability trials conducted by Kabalikat ng Pamilyang Pilipino in Manila have shown no significant deterioration in norethindrone or mestranol content, content uniformity, tablet hardness, disintegration time or blister pack integrity after blister packs without the protective overpack were exposed for 6 months to high humidity and temperatures as high as 60 degrees Celsius. Stability for longer than 6 months remains speculative and should be tested in actual field conditions. Within the limits of the study, however, these results suggest that OCs remain stable with or without the aluminum overpack. (full text)
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  14. 14

    Preventing contraceptive spoilage: guidelines for family planning program officers and administrators.

    Keeny SM; Rhodes C; Shearer SB

    [Unpublished] [1983]. 87 p.

    The project purpose was to collect into 1 internationally accessible reference source all available information on the stability, shelf life, and storage of contraceptives to help family planning program to avoid spoilage. This report reflects the suggestions, recommendations, and shared experience of nearly 100 men and women who work in family planning programs in developing countries, in international agencies which supply contraceptives and other assistance to those programs, and in private companies throughout the world that manufacture contraceptives. It covers the following: the problem of contraceptive spoilage, its consequences, and approaches to prevention (causes of spoilage, expiration dates, shelf-life of contraceptives); packaging, stability, and shelf-life of contraceptives (the importance of packaging, guidelines for packaging specifications, and the stability and shelf-life of different types of contraceptive products); efficient distrubution of contraceptives (planning vfor and ordering contraceptive supplies, shipping arrangements, receiving contraceptive supplies, storage of contraceptives, and distribution of contraceptives); and warehouse design considerations for the storage of contraceptives (locatioon and site criteria, contraceptive storage policy, space requirements, storage pallets and stocking, stacking heights, pallet capacities, height of warehouse ceiling, circulation space and operating areas, climatic limits, mechanical plant, and construction criteria). The consequences of contraceptive spoilage and damage are serious: unwanted pregnancies may occur; use confidence in the family planning program may be undermined; and scarce financial resources may be wasted. 6 main factors are involved in contraceptive spoilage; time; temperature; water and moisture; light; living organisms; and shock and stress. Efforts to minimize spoilage and damage can be guided by 4 very basic approaches: select the correct type and best quality of contraceptive products possible; ensure adequate packaging;deliver the contraceptives to program clients with a minimum of delay; and use transport and storage methods which maximally protect the contraceptives from water, moisture, light, heat, living organisms, and mechanical damage.
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  15. 15

    [Oral rehydration therapy].

    Faust H

    [Unpublished] 1983. Presented at the International Conference on Oral Rehydration Therapy, June 7-10, 1983, Washington, D.C. 11 p.

    The oral rehydration salts (ORS) developed and recommended by the World Health Organization (WHO) contains the needed ingredients for 1 litre of water: 20.0 gm glucose anhydrous, 3.5 gm sodium chloried, 2.5 gm sodium bicarbonate, and 1.5 gm potassium chloride. The choice of this particular formula was based primarily on physiological considerations and evidence of clinical acceptability, which was confirmed by various studies. Little attention was given at that time to possible chemical reactions and stability. For practical reasons and to avoid overdependency on the central procurement and global provision of ORS, WHO and the UN International Childrens Emergency Fund (UNICEF) have been encouraging the national and regional production of ORS. Both agencies have been supporting since 1979 local production through the transfer of "know how," the supply of equipment, raw materials, and packaging material. Guidelines for the production of ORS have been available since 1980. The main problem has been the stability of ORS. As the product has become more widely used and distributed, it has been found that even packets produced in industrialized countries may, after some time, turn yellow and even brown. Usually this occurs only under tropical conditions (hot and humid) and if the packets have not been properly sealed or the raw materials have not been dried to the required moisture content. In some developing countries the stability problem has been solved by packing the glucose or bicarbonate separately. The potential danger of misuse discouraged WHO from adopting this solution. The main approach to improve the stabliity of packets has been to recommend a further reduction of the moisture content of the raw materials and the mixture, the use of high quality packaging material, and suitably air conditioned and dehumidified production facilities. This solution was not feasible in some developing countries. A 2nd approach adopted was to search for a chemically more stable formulation with equal clinical efficiency that could be produced with all the ingredients mixed together. The most effective and convenient solution seemed to be to use a substitute for bicarbonate. Preliminary tests, terminated in August 1981, showed that trisodium citrate probably offered the best prospects as a substitute fior bicarbonate. Based on this WHO initiated testing of 3 different formulae with citrate for stability over a 3-month period by exposing them to various temperatures and packing materials, including aluminum foil and polyethylene. By the end of 1982 the tests confirmed that a composition with glucose anhydrous and trisodium citrate in place of sodium bicarbonate was the most stable of the tested compositions.
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  16. 16

    Final market introduction plan for low dose oral contraceptive, Family of the Future.

    Greenberg R

    [Unpublished] 1983 Aug 10. [42] p.

    This document presents a plan for introducing a low dose oral contraceptives (OC) into the product line of the social marketing program of Family of the Future (FOF), a private Egyptian family planning organization. The program currently markets 2 IUDs, condoms, and a foaming vaginal tablet primarily through pharmacies in Cairo and other urban areas of the country. The OC, which will be introduced into the product line in November, 1983, is manufactured in the US. The plan describes the OC marketing objectives, identifies the target audiences, and describes the communication strategy which will be used to promote the product. Information on the product's ingredients and package is provided. Pricing information is also provided. The marketing objectives are to 1) increase the number of current OC users from 1 million to 1,250,000 million by 1987, 2) increase the proportion of users who continue use for more than 2 years from 30%-60% by 1987, 3) increase FOF revenues, and 4) provide women with a low dose OC to minimize health risks. The target population will be urban married women who are either 1st time users or previous users who discontinued OC use. The name of the product will be Norminest R 28 + Fe. The OC has a 28-day regime and provides 21 tablets containing 0.50 mg norethindrone and 0.035 mg ethinyl estradiol and 7 iron tablets. The package insert will provide information in Arabic and English. Each package will contain 1 cycle and sell for pt. 35. Nordette and Microvlar are currently selling for pt. 32-35. Pt. 35 is the maximum ceiling allowed by the government. The price was set to maximize FOF revenues and to take into account consumer perceptions that price is an indicator of quality. Detailing and distribution targets are provided. By the end of 1984, 80% of all Egypt's pharmacies are expected to carry the FOF product, and by the end of 1985 pharmacy coverage is expected to be 100%. Sales for 1984 are expected to reach 450,000 cycles. Communication target audiences include potential users, influentials, and the medical community. Advertising of ethical products is not permitted; therefore, the advertising messages will be directed toward physicians and pharmacists, and indirect advertising will be used to reach the general public. The week preceding the launch of the product, a conference for physicians and pharmacists will be held. The marketing program will be carefully monitored and evaluated for 3-5 months following the launch date. The appendices contain 1) a description of the messages to be communicated to each target audience, 2) a detailed timetable, and 3) copies of the package insert in Arabic and English.
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  17. 17

    Caribbean Contraceptive Social Marketing Project: initial marketing plan. Chapters V-XII.

    Bayley R; Washchuck G

    [Unpublished] [1983]. [54] p.

    This initial marketing plan reviews the following: family planning levels and current activities; family planning activities through governments and family planning associations in Barbados, St. Lucia, and St. Vincent; commercial sector contraceptive sales; the design of the contraceptive social marketing project; the target market; the product; distribution; advertising/promotion; marketing research strategy and program evaluation; project management structure, evaluations, and quality control procedures; travel schedule for 1 year; project budget for 3 years; the monthly cash flow; and a time phased schedule of activities. The Contraceptive Prevalence Surveys completed recently in all 3 program countries -- Barbados, St. Lucia, and St Vincent -- provide current information on knowledge use, and non-use of contraceptives. Knowledge of family planning methods, particularly for oral contraceptives (OCs) and condoms was reported to be very high in all 3 countries. Awareness of most methods was lowest in St. Lucia, a country with strong Catholic affiliation. Contraceptive prevalence was highest in Barbados, which reports a 36.9% rate. St. Lucia and St. Vincent report 33.8% and 33.2%, respectively. Family planning is supported through government programs and family planning associations in all 3 program countries. OCs are normally distributed through pharmacies, government clinics, and family planning associations, but in the target countries OCs also are sold by some dispensing doctors. Condoms can be more widely distributed to pharmacies, supermarkets, minimarkets, and small shops. While OCs are currently available in all potential retail outlets in the program countries, condom availability has not achieved total coverage of the potential market. The target countries identified for the launch of the contraceptive social marketing project include Barbados, the largest market with approximately 60,000 women of reproductive age (WRA), St. Lucia, and St. Vincent, each with approximately 22-23,000 WRA. 3 broad audiences have been identified as targets for the project: young sexually active women below age 19, working women aged 20-35, and males. A net target market of 22,568 couples has been established. The program will be with single cycle standard and low dose OCs (Perle and Perle LD, respectively) and 1 condom presentation -- the plain Panther condom in a 3-pack. In the 1st year of the project (8 months of sales), it is estimated that 5% of the net target market or 3385 couples will be reached. A 25% increase in sales is projected for year 2, and a 40% increase in year 3 for the original market countries. The project proposes to use advertising and promotional material developed for the Jamaica program with modifications as necessary.
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  18. 18

    Nepal Contraceptive Retail Sales (CRS) Company Pvt. Ltd. at a glance.

    [Unpublished] [1983]. 11 p.

    The program objectives of the Nepal Contraceptive Retail Sales (CRS) Company include the following: to increase contraceptive sales by at least 15% each year, to market non-contraceptive health products in order to supplement the primary health care in Nepal; and to make CRS a cost effective program and to move progressively towards self sufficiency. The Nepal CRS Company Pvt. Ltd. is currently funded by the US Agency for International Development (USAID) Mission to Nepal. Revenues are generated by product sales, and contraceptives are supplied by USAID at no cost to CRS Company. The staff number 33 persons. Mission objectives are to help reduce Nepal's population growth rate by increasing awareness and availability of contraceptives by a full scale marketing program and to supplement and complement the national family planning program by marketing of contraceptive products through commercial retail outlets. The products are colored and plain lubricated and high quality condoms, medium dose oral contraceptives (OCs), low dose OCs, and foaming vaginal tablets. Promotion involves display contests to motivate retailers, store signs, mobile units and stickers to attract attention, and painted jeeps with loud speaker and cassette systems. All advertising and promotional materials are developed and produced under subcontract with a commercial advertising firm. Products proposed to be marketed in the future include oral rehydration salt, deworming drugs, and a high quality condom.
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  19. 19

    Ending the cigarette pandemic.

    Richmond JB

    New York State Journal of Medicine. 1983 Dec; 83(13):1259.

    1 year after the issuance of the original Surgeon General's report, Congress passed the Federal Cigarette Labeling Advertising Act, requiring all cigarette packages distributed in the US to carry a Surgeon General's warning that smoking may be hazardous to health. Congress pased the Public Health Cigarette Smoking Act in 1969. This banned cigarette advertising from radio and television. The Surgeon General published the most comprehensive volume on smoking ever issued in the US in 1979, the 15th anniversary of the 1st report. The data on cigarette smoking's adverse effects on health were overwhelming, and the press recognized this. No longer able to rely on journalists to cast doubt on the reliability of the data, the industry changed its strategy by attempting to portray smoking as a civil rights issue. The tobacco industry began to pour millions of dollars into campaigns to prevent the passage of municipal, state, and federal legislation that would ban cigarette advertising or restrict smoking in public places and at the work site. "Healthy People," the Surgeon General's 1st report on health promotion and disease prevention, emphasized the necessary future direction of medicine: prevention. Efforts to end the cigarette pandemic will need to focus on the following in the future: an end to the victimization of women; a greater focus on adolescents; more effective strategies for smoking cessation; more attention to clean indoor air rights; abandonment of recommendations to switch to low-tar, low-nicotine cigarettes; and revelation of chemical additives in cigarettes. The epidemiologists have now documented the devastating nature of the health problems attributable to cigarette smoking, but the minimal budgetary allocations to fight smoking testify to the lack of political will on the part of government.
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  20. 20

    Evaluation of illustrated support material of Maya pill.

    Bangladesh. Family Planning Social Marketing Project

    [Unpublished] [1983]. 17, [5] p.

    The Social Marketing Project (SMP) of Bangladesh developed an illustrated Maya (a regular dose oral contraceptive) packet insert of instructions for use and information on potential side effects and what to do about them. Later, the pictures were further clarified by adding a simple text for women who could read and also for those illiterate women who would be interested to have it read by someone else if they had difficulty in understanding the message. The desired material was prepared during 1980 and printed in early 1981. SMP has considered printing it on a large scale, but first wants to determine if this pamphlet is really useful to the Maya consumers. PIACT International agreed to fund a project in Bangladesh to evaluate this pamphlet. Objectives of the evaluation were to learn if the pamphlet is understood by Maya consumers and to compare knowledge of proper use of Maya, its side effects, and what to do about them between the consumers who received and those who did not receive the pamphlet along with the Maya pill packet. 4 markets from the district of Dacca were chosen: Manikogonj, Tongi, Joydebpur, and Norsingdi. From each market, a number of pharmacies were chosen. The selected pharmacies in each market were divided into 2 groups: 1 group of pharmacies was provided a number of pamphlets depending on their Maya sales of the preceding month; pharmacies in the other group were supplied only the forms to record the addresses of the illiterate Maya consumers during a 1-month period. 200 illiterate Maya consumers were randomly selected and interviewed from each of the study and control groups. A majority of the pamphlet recipients understood the messages in the pamphlets. The illustrated support material was more effective than the text material in communicating messages. Clarification of the pictures by adding simple text was found to be useful. The recipients of the pamphlet possessed better knowledge than the nonrecipients of the pamphlet with regard to proper use of Maya, its side effects, and what to do about the side effects. The SMP should use the illustrative support material of Maya as an insert in the Maya packet. In the future, the SMP should use only the pamphlet as an insert in the Maya packet. Some additional information should be added, such as the irregularity of menses due to the use of Maya and the benefits of the use of Maya for other than birth control.
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