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Arlington, Virginia, Partnership for Child Health Care, 1994. , 35,  p. (BASICS Trip Report; BASICS Technical Directive: 000 ML-00-012; USAID Contract No. HRN-6006-C-00-3031-00)In 1994, the USAID-supported BASICS project sent a team to Malawi to help USAID/Malawi, Pharmanova, Ltd., the Ministry of Health (MOH), and other participating groups develop a social marketing strategy for oral rehydration salts (ORS) and a new ORS package design. USAID agreed to buy raw materials and packaging material for the local manufacture and distribution of ORS. Pharmanova agreed to produce packaged ORS to supply MOH with 7 million ORS packets over 2 years. Pharmanova would manufacture 1.4 million more ORS packets to be sold commercially. The preliminary plan for the marketing of a new ORS product centers on marketing activities to promote the national launch of Pharmanova's ORS product scheduled for April 1995. The BASICS team developed marketing objectives and strategies that addressed major issues identified by the market situation analysis: development of a product identity and presenting the ORS product in a productive way to users, ORS distribution in rural areas to complement public sector distribution, improvement of health providers' and drug retailers' knowledge in oral rehydration therapy (ORT), and coordination of all ORS/ORT activities among UNICEF, MOH, USAID, Pharmanova, and other suppliers and professional associations. The team designed and managed a rapid qualitative study of consumer reaction to 5 graphic concepts, promotional copy, illustrated mixing instructions, and a list of potential product names in Chichewa. Based on this research, the silhouette package design, the product name of Madzi A Moyo, clear and direct statements of product benefits were chosen for ORS brand identity. Feedback from focus groups led to two revisions of the illustrated mixing instructions. Recommendations centered on coordination and implementation of the ORS marketing program, training of health professionals, mobilizing retailers, sustaining ORS marketing, designing a long-term sustainable strategy for ORS supply, and working with Pharmanova to strengthen other child survival activities in Malawi.
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)