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  1. 1
    056178

    Generic OCs bioequivalent, but much maligned.

    CONTRACEPTIVE TECHNOLOGY UPDATE. 1989 Jun; 10(6):77-81.

    Although generic oral contraceptives (OCs) are bioequivalent to brand-name formulations, many family planning professionals do not prescribe the significantly lower-priced generics. The Planned Parenthood Federation of America, for example, has refused to approve generic OCs for use in the organization's clinics, presumably because of concerns about their equivalent efficacy and safety. However, much of this skepticism may be fueled by misleading marketing by brand-name OC manufacturers. Sales representatives have reportedly told clinicians that generic OCs can be as much as 20% different from brand-name formulations, despite evidence collected by the US Food and Drug Administration confirming that there is virtually no difference except in terms of inert ingredients. In the case of many formulations, the variability between the generic and brand-name products is no different than the variability found between different lots of the same brand-name drug. Another obstacle to wider use of generic OCs is that discounts for large volume purchases make brand-name OCs the best buy for family planning clinics. Clinicians also note that clients complain of minor side effects whenever OC brands are changed, even if the compounds are the same. As the price of medication continues to rise, the more widespread availability of generic OCs will be especially important for teenagers and other low-income clients.
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  2. 2
    119388

    The decision makers. [editorial]

    Senanayake P

    British Journal of Family Planning. 1984 Jul; 10(37):37.

    This editorial takes a broad, international look at the worldwide implications of decisions taken in the United Kingdom (U.K.) and the US with regard to family planning. National authorities, like the U.K. Committee for Safety of Medicines (CSM) of the US Food and Drug Administration, address issues concerning the safety of pharmaceutical products in terms of risk/benefit ratios applicable in their countries. International repercussions of US and U.K. decision making must be considered, especially in the area of pharmaceutical products, where they have an important world leadership role. Much of the adverse publicity of the use of Depo-Provera has focused on the fact that it was not approved for longterm use in the U.K. and the US. It is not equally known that the CSM, IPPF and WHO recommeded approval, but were overruled by the licensing agencies. The controversy caused by the Lancet articles of Professors with family planning doctors. At present several family planning issues in the U.K., such as contraception for minors, have implications for other countries. A campaign is being undertaken to enforce 'Squeal' laws in the U.K. and the US requiring parental consent for their teenagers under 16 to use contraceptives. In some developing countries, urbanization heightens the problem of adolescent sexuality. Carefully designed adolescent programs, stressing the need for adequate counseling, are needed. Many issues of international interest go unnoticed in the U.K. International agencies, like the WHO and UNiCEF, have embarked on a global program to promote lactation both for its benficial effects on an infant's growth and development and for birth spacing effects. It may be of benefit to family planning professionals in the U.K. to pay attention to international activity in such issues.
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