title: Legal and regulatory aspects of prescribing and marketing emergency contraception in Nigeria.
abstract: Emergency contraception remains so little used or understood and the lack of its awareness can be traced to a myriad of factors including legal and regulatory obstacles. The aim of this study was to determine the legal and regulatory aspects of dispensing or marketing a contraceptive method for reasons (especially emergency purposes) other than stated by the manufacturers. The existing drugs' and devices' regulatory systems in Nigeria, especially those governing family planning methods, were reviewed. A questionnaire was administered to 363 health workers, comprising of physicians, pharmacists, nurses and midwives, to determine the implications of dispensing some currently available oral contraceptives (OCs) for emergency purposes despite the fact that there is no explicit description of emergency use in the labelling of such drugs. In addition, in-depth interviews were conducted with regulatory bodies. It was observed that, with the exception of Postinor, the drug manufacturers' leaflets did not indicate that they could be used for emergency contraceptive purposes. Although 64.5% of the healthcare providers were aware that OCs and intrauterine contraceptive devices (IUCDs) can be used for emergency purposes, 42.1% actually prescribed or recommended them. Many health workers (62.3%) were unaware of any legal implication with regards to prescribing unregistered drugs in Nigeria. The existing guidelines stipulate that a manufacturer or marketer should 're-register' a product if a new indication or use not contained in the initial application was found later. To satisfy legal requirements, it does appear that the currently available OCs and IUCDs in Nigeria must be labelled and registered for emergency contraceptive purposes.
mesh_terms: D000328:Adult; D003267:Contraception / Q000706:statistics & numerical data*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D016656:Family Planning Policy / Q000331:legislation & jurisprudence; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D008297:Male; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D008875:Middle Aged; D009549:Nigeria; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data