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Your search found 9 Results

  1. 1

    Developing and testing a generic job aid for malaria rapid diagnostic tests (RDTs). Field report.

    Rennie W; Harvey SA

    Bethesda, Maryland, University Research Company, Quality Assurance Project, 2004 Dec. 47 p. (QAP / WHO Field Report)

    The traditional approach to malaria diagnosis has been examination by microscope of a thick blood smear from the individual suspected of being infected. In an attempt to provide a more rapid alternative, companies worldwide have developed malaria rapid diagnostic tests (RDTs). Although RDTs can be effectively used in clinical settings by trained personnel, their greatest potential use is in rural areas with limited access to health and laboratory facilities. Using RDTs for diagnosis at the community level will shorten the delay between the onset of symptoms and the beginning of appropriate treatment. It will also slow development of resistance and lead to significant cost savings by avoiding unnecessary use of antimalarials. However, achieving a high level of sensitivity and specificity with RDTs in this context will require a product designed, labelled, and explained so that community health workers (CHWs) can use it accurately with minimal formal training and supervision. In partnership with theWHO Regional Office for the Western Pacific, the Quality Assurance Project (QAP) carried out quality-design research in the Philippines and the Lao People's Democratic Republic to develop and test a generic RDT job aid, mainly pictorial, that could be adapted with little modification for use with different RDT products and in different cultural settings by health workers with low literacy skills and with little or no prior training in product use. (author's)
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  2. 2

    Access to HIV / AIDS drugs and diagnostics of acceptable quality. Procurement Quality and Sourcing project. Manufacturers and suppliers whose HIV-related medicines have been found acceptable, in principle, for procurement by UN agencies. 18th ed.

    World Health Organization [WHO]; UNICEF; Joint United Nations Programme on HIV / AIDS [UNAIDS]; United Nations Population Fund [UNFPA]

    Geneva, Switzerland, WHO, 2004 Aug 9. 19 p.

    A "Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality" was actively started by WHO in collaboration with other United Nations Organizations (UNAIDS, UNICEF, and UNFPA) in March 2001. The World Bank supports this initiative. The background to the project is described in the project description. The procedure for assessing the acceptability in principle of HIV/AIDS drugs comprises various components including 1) The evaluation of product data and information provided by manufacturers and suppliers, and 2) Inspection of manufacturing sites. Due to the particular properties of several substances used in some pharmaceutical finished dosage forms in the treatment of HIV/AIDS (e.g. chiral activity, isomerism, sensitivity to relative humidity etc.), and the current status where there are no Pharmacopoeia monographs and standards available for several substances and finished products, WHO appointed experts have performed a comprehensive and rigorous evaluation of the products included in the list, with a view to establishing their compliance with international standards. (excerpt)
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  3. 3
    Peer Reviewed

    More women are looking at intrauterine devices.

    Contraceptive Technology Update. 2004 Nov; 25(11):[3] p..

    Are more women at your family planning facility requesting information on intrauterine contraception? Chances are you are seeing an increase in interest: Almost 30% of respondents to the 2004 Contraceptive Technology Update Contraception Survey say they have performed six to 25 intrauterine device (IUD) insertions in the last year, up slightly from 2003’s figures. The popularity of the levonorgestrel intrauterine system (Mirena IUS, Berlex Laboratories, Montville, NJ) led to an increase in the number of IUD insertions, confirms Joe Childress, MD, an obstetrician/ gynecologist in private practice in San Antonio. Women in the United States have two choices when it comes to intrauterine contraception: the Mirena and the Copper T 380A IUD (ParaGard, FEI Women’s Health, North Tonawanda, NY). More IUD insertions are being performed at the Pinal County Health Department, a public health facility in Florence, AZ, reports Carolyn Brown, RNP, nurse practitioner. The facility uses ParaGard IUDs. (excerpt)
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  4. 4
    Peer Reviewed

    New labeling for the pill: will it change how you prescribe oral contraceptives?

    Contraceptive Technology Update. 2004 Sep; 25(9):[4] p..

    When it comes to using combined oral contraceptives (OCs), clinicians and patients look to drug package labeling for the most current information on how the Pill may be safely and effectively used. If new industry guidance for package labeling goes into effect, however, combined OC labels may not reflect the most current thinking in contraceptive provision. While the guidance offers a more simplified approach to the label and patient instructions, several women’s health groups have called for the directive to contain more updated medical information, a more thorough explanation about contraceptive method failure rates, and expanded information on the noncontraceptive benefits of the Pill. “My understanding is that package labeling is intended to provide accurate and up-to-date drug information for consumers and providers,” says David Grimes, MD, vice president of biomedical affairs at Family Health International in Research Triangle Park, NC. “The proposed labeling I reviewed was neither accurate nor up to date.” Groups such as the American College of Obstetricians and Gynecologists (ACOG), National Association of Nurse Practitioners in Women’s Health (NPWH), both based in Washington, DC; Planned Parenthood Federation of America (PPFA) in New York City; and drug manufacturers such as Raritan, NJ-based Ortho-McNeil Pharmaceutical and Philadelphia-based Wyeth Pharmaceuticals, have filed comments with the regulatory agency. The deadline for filing comments was May 4, 2004. The FDA is analyzing the comments, says Susan Cruzan, FDA spokeswoman. (excerpt)
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  5. 5
    Peer Reviewed

    Bulletin: Emergency contraception moves closer to over-the-counter.

    Contraceptive Technology Update. 2004 Feb; 25(2):[3] p..

    This month may well mark a milestone in women’s health if the Food and Drug Administration (FDA) follows the recommendation of two of its expert advisory committees to approve the over-the-counter (OTC) sale of Plan B, the levonorgestrel-only emergency contraceptive (EC). In a joint meeting of the FDA’s Reproductive Health Drugs and Nonprescription Drugs Advisory committees, members voted 23 to 4 to recommend OTC sale of the drug. The final decision rests with the FDA’s commissioner, Mark McClellan, MD, MPH. While the FDA doesn’t always follow its advisory panels’ recommendations, it would be “surprising” if it did not in this case, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University. “There wasn’t much opposition, and there was considerable support” for making the EC drug available on retail pharmacy shelves, says Trussell, who was a member of the FDA joint committee. (excerpt)
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  6. 6
    Peer Reviewed

    First chewable OC enters U.S. market.

    Contraceptive Technology Update. 2004 Feb; 25(2):[2] p..

    Successful pill-taking is an important component for women who use oral contraceptives (OCs). Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States. Will a chewable contraceptive aid in pill-taking compliance? The Food and Drug Administration (FDA) has just approved the first such product. Look for the launch of Ovcon 35 in late spring, says Katie MacFarlane, PharmD, vice president of marketing for Galen Holdings and Warner Chilcott, based in Rockaway, NJ. When a pill is reformulated into a chewable form, it must be flavored to mask the chalky taste of the active ingredient, says Jeff Worthington, managing director of food and pharmaceutical technologies at Cambridge, MA-based TIAX, an independent and privately held technology development and consulting firm that aids companies in developing palatable pharmaceuticals, nutritional products, foods, and beverages. (excerpt)
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  7. 7

    Costing nevirapine delivery to infants: a Zambian case study.

    Zellner S; Musau S

    Bethesda, Maryland, Abt Associates, Partners for Health Reform Plus Project, 2004 Aug. [36] p. (USAID Contract No. HRN-C-00-00-00019-00)

    The United States Agency for International Development invited the Partners for Health Reformplus to estimate costs associated with the packaging of infant doses of Nevirapine in Zambia. The costs of following four scenarios were examined in this exercise: 1) preparation and administration of Nevirapine by a nurse immediately after birth, 2) preparation of Nevirapine in batches prepared by either a nurse or nurse’s aide, 3) a semi-automated approach of pre-filled and packaged Nevirapine syringes, and 4) a fully automated approach using UnijectDP pre-filled with Nevirapine. Findings show that, at all dose levels, administration by a nurse after birth is the most cost-effective scenario. However, if other important factors, such as limited access to hospital facilities, are taken into consideration, then the semi-automated or Uniject approaches may be more suitable. (author's)
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  8. 8
    Peer Reviewed

    Hearing addresses condoms for HPV prevention.

    Christopher A

    Journal of the National Cancer Institute. 2004 Jul 7; 96(13):985.

    A politically challenged debate about labeling condoms with warnings about the link between human papillomavirus (HPV) and cervical cancer has erupted following a related Congressional hearing on the issue in March. Although the dispute centers on the protection of women from cervical cancer, the debate is just as much about ideology: premarital abstinence or monogamy in marriage versus condom use for those who choose to be sexually active. The hearings, called by Rep. Mark Souder (R-lnd.) at the urging of Tom Coburn, M.D., co-chair of the Presidential Advisory Committee on HIV/AIDS continue to raise questions about a public law Coburn authored in 2000 and that former President Bill Clinton signed days before leaving office. Souder confronted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention with his belief that the agencies had not complied with the public law. (excerpt)
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  9. 9
    Peer Reviewed

    Reading nutrition labels and fat consumption in adolescents.

    Huang TT; Kaur H; McCarter KS; Nazir N; Choi WS

    Journal of Adolescent Health. 2004; 35:399-401.

    We studied the relationship between reading nutrition labels and percent calorie intake from fat. In adolescent boys, reading nutrition labels was associated with higher fat intake. In girls, fat intake did not differ by frequency of nutrition label reading. Nutrition label reading does not translate into healthier diet in adolescents. (author's)
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