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Seattle, Washington, PATH, 1998.  p.Emergency Contraceptive Pills (ECPs) must be taken within 3 days after sex. Any of the birth control pills listed below can be used as ECPs. Use only the type of pill your health care provider prescribed for you. Use only one type of pill. One hour before the first ECP dose, take an anti- nausea medicine (like Dramamine II or Benadryl) to reduce the chance of nausea. Repeat according to labeled instructions. This may make you feel tired, so don't drive or drink any alcohol. Take the first ECP dose as soon as convenient within 3 days (72 hours) after unprotected sex (try to time the first dose so that the timing of the second dose will be convenient). Take the second ECP dose 12 hours after the first dose. Important: Do not take any extra ECPs. More pills will not make the treatment work better. More pills will increase your risk of feeling sick to your stomach. (excerpt)
Journal of the American Medical Women's Association. 1999 Spring; 54(2):101-2.Jeffrey N. Gibbs of Hyman, Phelps, and McNamara in Washington, District of Colombia, commented on the Center for Reproductive Law and Policy's (CRLP) article on legal issues related to the provision of emergency contraceptive pills (ECPs) by health care providers. Gibbs expressed concerns that the repackaging of birth control pills as ECPs may implicate the Food and Drug Authority (FDA) regulations to greater extent than the CRLP article discussed. However, Bonnie Scott Jones of CRLP thinks that such concerns are overly cautionary although pertinent to the general issues of drug repackaging. The failure to tailor those concerns to the specific circumstances discussed in the article has led Gibbs to a far more cautious position than necessary. It is noted that the FDA has explicitly recognized the safety and efficacy of using certain birth control pills as ECPs, and it has published guidelines for ECP delivery, as well as ECP instructions for patients. In this perspective, the FDA cannot and will not attempt to regulate medical judgment in packaging and dispensing these ECPs for their own patients.
Journal of the American Medical Women's Association. 1999 Spring; 54(2):101.The Center for Reproductive Law and Policy's article by Jones contains a useful discussion. However, it is believed that it oversimplifies in some significant respects the Food and Drug Administration's (FDA) regulatory issues associated with the repackaging of birth control pills into doses appropriate for emergency postcoital contraception. It takes the position that medical personnel and health care providers who repackage drugs are not barred by federal law from such activity. This conclusion was based on the "practice of medicine" exception. Nevertheless, the Food, Drug, and Cosmetic Act does not have a provision expressly exempting the practice of medicine from FDA regulation. Indeed, the FDA has stated that there is no such blanket exemption; their regulations specifically define drug repackagers as manufacturers. Moreover, the repackaging of birth control pills may have serious consequences, including low quality or composition of the drugs; inappropriate expiration dating; and inconsistent use of the drug. Hence, it is noted that the repackaging of birth control pills and the relabeling of the pills may present more significant FDA issues than discussed in the article.
Emergency contraceptive pills: common legal questions about prescribing, dispensing, repackaging, and advertising.
New York, New York, Center for Reproductive Law and Policy, . 9 p. (Reproductive Freedom in Focus)Health care providers in the US and abroad have long used oral contraceptive pills as postcoital regimens (emergency contraceptive pills or ECPs) to prevent pregnancy. Numerous studies have documented the safety and efficacy of these “morning after” ECPs. Nonetheless, the manufacturers of the oral contraceptives currently available in this country have not sought the approval of the US Food and Drug Administration to label and market their products for postcoital use. This issue of In Focus answers common legal questions about dispensing, repackaging, and advertising oral contraceptives as “off-label” ECPs. It also addresses questions about prescribing, and liability related to provision of both “Off-label” ECP and designated ECP products.
Emergency contraceptive pills: what does the law say about prescribing, dispensing, repackaging, and advertising?
JOURNAL OF THE AMERICAN MEDICAL WOMENS ASSOCIATION. 1998; 53(5 Suppl 2):233-7.Despite US Food and Drug Administration (FDA) approval of certain combined oral contraceptives (OCs) for purposes of emergency contraception, many health care providers are unclear about the legal aspects of off-label use of existing products. This paper provides an overview of the legal issues related to prescribing, dispensing, repackaging, and advertising emergency contraception. There are no FDA restrictions on a physician's authority to prescribe an approved drug for an off-label use. States vary widely in the extent to which they grant prescribing authority to non-physician health care providers (e.g., pharmacists) and the limits they place on that authority. Physicians who directly dispense emergency contraceptive pills should adhere to state dispensing requirements, which generally include mandates for labeling and packaging. In some states, providers with dispensing authority may repackage OCs to dispense to their patients for postcoital use. Health care providers (but not manufacturers) can use advertisements announcing the availability of emergency contraceptive services at their facility. Overall, most legal issues related to use of OCs for emergency contraception constitute the "practice of medicine," which the FDA does not regulate. There is no known case in the US in which liability has been imposed against a health care provider in association with the provision of emergency contraception. In fact, malpractice liability may be far greater for providers who do not provide this regimen to medically suitable women who have had unprotected intercourse and do not wish to become pregnant.
LIFELINES. 1997 Oct; 1(5):28-31.The use of combined oral contraceptives (OCs) for emergency contraception represents an important strategy for preventing unwanted pregnancy. Despite the efficacy of this approach and its recent (1997) approval by the US Food and Drug Administration, many health care providers remain uninformed. In response, several national organizations--including the American College of Obstetricians and Gynecologists' Program for Appropriate Technology in Health--are launching information initiatives about this use of OCs. In anticipation of increased requests from US women for postcoital contraception, clinical facilities are urged to create practice guidelines for counseling and method distribution. Women should be advised to take the initial dose of the appropriate number and color of combination of OCs within 72 hours of exposure, followed by a second dose 12 hours later. Increased awareness of OCs as emergency contraception could result in separate packaging of the two doses of four combination pills along with patient instructions. Were such a product to be packaged, family planning clients could be provided with emergency contraception at the same time they receive prescriptions for a regular contraceptive method.
BMJ. British Medical Journal. 1993 Apr 3; 306(6882):931.D. R. Bromham and R. S. V. Cartmill report the knowledge and use of secondary contraception among patients requesting termination of pregnancy at a fertility control unit. They found that many patients had switched from using the pill to condoms for contraception, hoping to decrease any risk of contracting AIDS. A considerable number of the women said that a condom had leaked and some that one had split. The authors concluded that an increasing proportion of unplanned pregnancies were due to condom failure. They also found that many women were unaware of the availability of the postcoital pill--popularly and perhaps misleadingly called the morning after pill, although it is recommended for use up to 72 hours after any risk. This exactly reflects my experience in seeing a large number of women who have sought a termination of pregnancy in Liverpool. I wrote to 2 large manufacturers of condoms, pointed out my findings, and suggested that it would be helpful if they included in their product's leaflet information about the postcoital pill, how to obtain it, and in what circumstances to use it. This was in July 1989, and by November I had received considered replies from both manufacturers. One manufacturer wrote: "To incorporate such wording as you suggest within our instructions would imply that the product has a higher failure rate than is actually the case and cast doubt upon the advisability of its use." The other, having said that most "failures" (its inverted commas) are really related to the users and not the product, went on to say: "I find it hard to envisage how such advice could be given without causing potential damage to our own product's reputation." Manufacturers competing in the market may well have a problem, but surely a form of words could be agreed and, with government help, made mandatory for inclusion in all manufacturers' information sheets. (full text)