快樂小藥師 Im pharmacist nichts glücklich

聯邦食品暨藥物管理局(FDA)30日宣布，15歲及以上的婦女在購買事後避孕丸「B計畫」(Plan B One-Step)時，不需要處方。FDA是在法院下令該局須在5月6日前取消「B 計畫」購買年齡限制的前數日，做出此決定。

過去「B計畫」是在藥局櫃台出售，購買者必須證明自己滿17歲，才能不用處方購買此藥，FDA於30日的決定把購買者年齡的限制降低，也使此藥可以放在雜貨店的一般貨架上，與其他婦女衛生用品和保險套一起出售，但購買者必須在付帳時證明自己的年齡。

FDA說，「B計畫」的包裝將有一個產品密碼，促使收銀員去查證購買者的年齡，任何人如果不能提供年齡證明(如駕照、出生證明、護照)，就不能購買。

對政府提出訴訟的婦女團體「生育權利中心」主席南西‧諾索普說，FDA的這個行動還不夠，未能解決各年齡婦女獲得「B計畫」的障礙，如她們去雜貨店時未攜帶年齡證明，所以該團體將繼續抗爭。

美國每年有一半的懷孕是意外的，醫生組織說，讓婦女更容易獲得事後避孕丸，將有助於降低此數字。事後避孕丸含有較高劑量的普通避孕藥劑，在未加防護的性行為後72小時內服用，可以把懷孕的機會減低89%。

US health regulators today approved the emergency oral contraceptive Plan B One-Step (Teva Women's Health, Inc) for sale without a prescription to girls aged 15 years and older. The active ingredient in Plan B is levonorgestrel.

In a statement, the US Food and Drug Administration (FDA) said Plan B will now be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified."

"Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer's age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft," the FDA said.

Teva will make the product available in retail outlets with an on-site pharmacy, where it generally will be available in the family-planning or female health aisles.

Plan B One-Step — also known as the morning-after pill — is intended to reduce the possibility of pregnancy following unprotected sexual intercourse, if another form of birth control such as a condom was not used or failed. Plan B One-Step is a single-dose pill (1.5-mg tablet). It is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus, the FDA said.

"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," said FDA Commissioner Margaret A. Hamburg, MD, in the release.

"The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease," she added. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a healthcare provider, the FDA said.

Teva said it will educate consumers, pharmacy staff, and healthcare professionals about the product's new status. It has also indicated its willingness to conduct an audit of the age-verification practices after the product is approved to ensure that the age limitation is being followed.

Early in April, as reported by Medscape Medical News , a federal judge ordered the FDA to make Plan B One-Step available to all adolescent girls without a prescription within 30 days.

The FDA today said approval of Teva's amended application for Plan B One-Step is "independent of that litigation and this decision is not intended to address the judge's ruling."

"The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older," the agency said.