April 15, 2002

The morning-after pill: coming to a drugstore near you?

By Tess Laidlaw
tlaidlaw@uwo.ca

Eighteen-year-old Mandy Patrick woke up the next morning to the chilling knowledge that she'd had unprotected sex the night before. "When I realized what had happened," she said, "I knew that I would have to take emergency contraception."

A condom breaks, a pill is missed. A woman is sexually assaulted, or "the heat of the moment" obscures reason. Accidents happen all the time -- including at 4 a.m. Saturday morning when all the family physicians are fast asleep.

Courtesy of the BBC

Emergency contraception pills: when you need them, can you get them?

Every day, thousands of women use the ECP. The longer a woman waits before taking it, the less effective it is at preventing pregnancy. In fact, she needs to take it within 72 hours of unprotected sex. After a fertilized egg implants in the wall of the uterus, the ECP has no effect.

This sets the ECP apart from the "abortion pill" RU-486, with which it is often confused. RU-486 can abort an established pregnancy of up to several weeks.

So far in Canada, a woman can only obtain the ECP without a prescription in British Columbia and Quebec. At any time of the day or night, she can stop by a pharmacy and get the pill within 15 minutes -- a more convenient experience than Patrick's wait at the ER in Sackville, N.B.

Governments around the world are working to make the pill more accessible and to increase awareness of it. A British ad for a common ECP reads, "Missed pill. Oooops. Emergency contraception!!! Quick. Pharmacy. Buy Levonelle." The pill is freely available in most parts of Asia, in Brazil, in Israel, over the Internet in the U.S. and the list goes on.

Courtesy of the University of Reading, U.K.

Levonelle is the British version of Plan B.

But it's also banned in some countries, including the Philippines and Chile. And here in Canada, in provinces where it's been approved for over-the-counter sale, there are pharmacies and chain stores, including Wal-Mart, that refuse to dispense the pill. Some physicians will not prescribe it.

The benefits of the pill are unassailable. A rape victim may be spared further pain. A teenager may escape irrevocable changes to her young life. A woman, or couple, unable to financially support a child may win a reprieve from a life of poverty.

But if the pill goes over-the-counter, will that teenager get the counselling she needs? If the rape victim does become pregnant, will anyone be there to offer her the support she needs? If a woman experiences grave side effects because of the pill, who will she tell?

There are other criticisms. No studies have been performed to confirm that the ECP is safe for very young women -- if 12-year-old girls can be considered women. And yes, 12-year-old girls can easily access the ECP, without their parents' knowledge.

The long-term effects of the ECP on repeat users have not been studied. Critics fear the pill may impact a woman's chances of developing breast cancer, infertility or of having a healthy baby if she takes it while pregnant.

Then there is the common proposition that the ECP causes abortions. Most physicians who prescribe the ECP will explain that it does not cause abortion, including the doctor that was on duty when Patrick came in.

Dr. Bill Fisher, professor of obstetrics and gynecology at the University of Western Ontario, is no different. Fisher, who has been studying contraception for 25 years, says that even in cases where women are trying to get pregnant, 40 per cent of fertilized eggs do not implant and are lost naturally. "So if that were regarded as abortion then most couples would have experienced abortion."

That is exactly where the confusion arises. If a woman's egg is fertilized, is she pregnant? Or is she only pregnant when the egg actually implants?

Dr. Will Johnston, president of the Canadian organization Physicians for Life, says that proponents of the pill still do not understand exactly how it works. Indeed, some of the pill's manufacturers say the same thing. The pill is thought to function in several ways -- it may simply postpone ovulation or disrupt the movement of the egg and sperm, depending on when during her menstrual cycle a woman takes it. But in some cases, there is the possibility that the ECP prevents implantation or otherwise affects the fertilized egg so that it cannot implant. This could cause the loss of a fertilized egg and thus, according to some, an abortion.

"The confusion is aggravated by the current attempt to redefine pregnancy as occurring after implantation," said Dr. Robert Pankratz, vice-president of Physicians for Life. "It is a basic fact of human embryology that life begins at conception."

The definition of "conception" has been accepted by the U.S. Supreme Court as the fertilization of an egg cell by a sperm cell. Therefore, opponents argue, something acting after conception can no longer be called "contraception." As well, scientists can create an embryo without the use of a womb -- or anything akin to implantation.

"My personal position is based on scientific literature in that pregnancy is defined at the moment of implantation," said Mark Kearney, a Toronto pharmacist who dispenses the ECP, and a spokesperson for the Canadian Pharmacists Association. "Since this medicine does not work at all after implantation has occurred I don't see how it could be classified as an abortifacient."

The issue, the moment pregnancy occurs, is currently before the British High Court, where an anti-abortion group has launched a challenge to over-the-counter sales of Levonelle.

Regardless of what the courts or the scientific literature say, it falls to women like Patrick to make up their own minds. "I still felt badly about it," said Patrick, "like I was doing something very much against my morals. I am completely pro-choice, but I could never have an abortion."

The ECP, also known as the morning-after pill or MAP, was first used in the mid-1960s by one of the first family-planning advocates. Dutch physician Dr. Ary Haspels prescribed high estrogen doses to a 13-year-old rape victim. The treatment had previously been used successfully on animals.

Over the past 30 years, emergency contraception has consisted largely of the Yuzpe regimen, a synthetic hormone treatment of estrogen and progestin using high doses of oral contraceptives developed by Canadian physician Dr. Albert Yuzpe at the University of Western Ontario.

Emergency contraception uses the same ingredients and works by essentially the same methods as do regular birth control pills. A woman's menstrual cycle is regulated by complementary surges in the hormones estrogen and progesterone. The hormones regulate the release and movement of an egg, the production of cervical mucous, and the level of receptiveness of the wall of the uterus.

The synthetic hormones in birth control pills superimpose their message over the woman's own hormones, stopping an egg from being released or making it impossible for a fertilized egg to implant.

To achieve such results in an emergency situation, the hormone dose must be higher. For years, doctors gave high doses of regular birth control pills as emergency contraception. The hormone dose in the ECP is so high that it often causes nausea and sometimes vomiting, as well as breast tenderness, headaches and spotting. Subsequent menstrual periods may be heavier or more painful. Manufacturers also state that the ECP may increase a woman's chance of developing an ectopic pregnancy, a potentially fatal condition in which the fertilized egg implants somewhere other than the uterus.

Megan Wilkes (not her real name) has used the ECP twice. "I felt pretty sick -- I got nausea, I just lay there and did nothing all day. You know you can't throw it up so it's basically just lie there and do everything you can to keep it down."

The side effects of newer versions of the ECP are milder than older treatments, including the Yuzpe regimen. One version, approved for sale in Canada as a prescription drug in February 2000, is sold under the trade name Plan B. Plan B is a progestin-only pill that is sold around the world under various trade names including Levonelle, the British version.

In most Canadian provinces, the pill is available only from walk-in clinics, emergency rooms, family doctors or public health nurses.

Courtesy of Plan B

A campaign in Washington, D.C. aims to increase awareness.

However, early in 2002, the Society of Obstetricians and Gynecologists of Canada approached the Canadian distributor of the drug, Paladin Labs, Inc. of Montreal, to encourage it to submit a request to Health Canada that the pill be switched from prescription-only to non-prescription status. The process requires that Paladin Labs submit scientific data to prove that the safety and efficacy of the drug will be maintained on non-prescription status.

"It's being able to give the tools to women that they need when they need them," said Christiane Menard, the society's director of communications.

While Health Canada can designate drugs as prescription or non-prescription, the National Association of Pharmacy Regulatory Authorities then recommends to the respective provincial colleges of pharmacy whether the drug should be truly "over-the-counter" or "behind-the-counter." In the second case, the customer would need to request the drug from the pharmacist.

NAPRA has already made a recommendation that the ECP be designated as a behind-the-counter drug, said Menard, "so that patients get a bit of counselling in what they need to do for contraception needs."

The effectiveness of the scheme is currently being studied in 40 pharmacies in Ontario. The Sunnybrook and Women's College Hospital is running a year-long pilot project in the North York, Scarborough and Rexdale areas of Toronto until June, 2002.

The project is testing a finely-tuned method of dispensing the pills, replete with a phone-in information and counselling line. A great deal of paper is involved for a woman requesting the ECP -- forms for the study investigators, for the pharmacist's records, and, as the pill is officially still a prescription-only drug in Ontario, for a physician to sign. Pharmacists have been handing out about 450 ECPs per month, an unexpectedly high number.

Often the customer simply has questions about how the pill works, but sometimes the pharmacist may suspect from information the customer has given that an assault has occurred or that the woman should begin a regular form of birth control. Participating pharmacists have been trained to deal with such possibilities, and are able to make referrals to another health care provider if necessary.

The dispensation method being tested in the pilot project may or may not continue in Ontario after the project's close. "The question of what will happen after this project is a good one. We're all wondering that right now," said Anna Pancham, a researcher with Planned Parenthood of Toronto and co-ordinator for the pilot project. "We're just some researchers doing this project to assess this way of getting the ECP. It'll be up to whoever decides that it should continue."

Courtesy of the Planned Parenthood Federation of Canada

The Planned Parenthood Federation of Canada gives women a number to call for emergency contraception.

The question of who should distribute the pills and how is contentious. "I think there needs to be some sort of contact with a health care professional," says Hollie Robinson, public health nurse at the birth control clinic run four days a week by the Middlesex London Health Unit in London, Ont.

Nurses are authorized to administer prescription drugs under medical directives that prescribe specific circumstances under which the nurse may give the drug. If the conditions are not met, the patient must be referred to a physician.

Although she's sure the pills come with information, Robinson says there's no guarantee that pharmacy customers will read it. At the MLHU clinic, clients are thoroughly counselled by a nurse, a blood pressure reading is taken and a follow-up appointment is made. This ensures that a woman who may have a health condition that would make the pill unsuitable would not receive it by mistake, and should she indeed become pregnant, she will have access to counselling and support.

"This is a family planning clinic so this is something we specialize in, but you still hope the service wouldn't really differ in another place," says Robinson. But of course, it does.

Wilkes said the after-hours clinic from which she received the ECP had a rather lackadaisical attitude. "I think they're probably very used to girls coming in. They were kind of like 'Okay, don't do it again.' I think I was in and out in 10 minutes."

While some physicians may take as little time with patients as it takes to say, "Why aren't you on the birth control pill?" and "You may feel nauseous," others give Gravol tablets with the ECP, explain how the pill works and discuss whether or not it causes abortion. Blood pressure readings are not routinely taken, nor is the patient's family doctor contacted.

Neither the ECP nor the regular birth control pill should be taken if a woman has high blood pressure, certain migraine conditions, or if there's a possible drug interaction. The provider routinely takes a medical history, but a patient may be unaware of her high blood pressure condition or unwilling to disclose other health conditions. The manufacturer of Plan B warns that the pill should not be used again in the current menstrual cycle, yet women are not routinely informed of this.

There is no method in place or under discussion for standardizing the processing of women requesting the ECP.

Kearney says that if Plan B is approved as a non-prescription drug, under the current law pharmacists would not be required to take special training to dispense it.

For the most part, he believes pharmacists are capable of discussing the drug and deciding whether or not it's appropriate for the customer. However, he believes additional training would be useful in situations where the pharmacist may suspect the women is being coerced into taking the drug, or if she is requesting it over 72 hours from unprotected sex.

"That being said, if for example some drug plans decide to pay for a pharmacist's counselling services which is the ultimate aim, … then we may have to show that pharmacists have had a certain amount of training and in doing that we'll be guaranteeing a certain level of practice," said Kearney. "That may be an issue where people would actually have to be certified."

The concern is a big one for parents. In Ontario, under the Health Care Consent Act, if a provider of the ECP feels that a woman understands why she needs the treatment, what the risks are, and what she needs to do to prevent a recurrence, then the provider is obliged to give the treatment -- even if the customer is only 12 years old.

Jenny Bacon has become a critic of Britain's current emergency contraception legislation, which makes the ECP available to women 16 and up over-the-counter. Bacon's daughter Caroline suffered a fatal stroke at 15. She was prescribed the birth control pill at the age of 14 without her parents' knowledge. The prescribing clinic failed to check with Caroline's physician, who would have told them that Caroline had a severe migraine condition that pre-empted her suitability as a candidate for the pill.

"I believe the morning-after pill should only be prescribed by a doctor and used by adult women," Bacon said in an e-mail interview. "Levonelle is a massive dose of hormones, the equivalent of almost two months' worth of the mini-pill in less than a day."

The ECP contains the same hormones as the regular birth control pill, and is administered in higher doses. Aside from aggravating existing health conditions, repeat use of the ECP may increase the risk of developing deep-vein thrombosis, a blood clotting condition that can be fatal.

When drugs come through clinical trials and are approved for sale, consumers essentially become the subjects of a huge clinical trial. Records of adverse drug reactions that may accumulate through years of use by thousands of patients can result in changes being made to the drug's usage, or in the drug being pulled from the market.

Bacon fears that once the dispensing of the ECP is removed from the realm of the family doctor, the ability to track adverse reactions in patients may become more difficult, as a woman may only interact with the provider once.

Neither Health Canada, the SOGC, nor the majority of physicians have concerns about the safety of the ECP.

"The tendency is to look at the risk (of the ECP) compared to sitting on the beach drinking lemonade," said Fisher. "It has to be considered relative to being pregnant. All forms of contraception are safer than being pregnant."

He says the comparison to the mini-pill is an unfair one. "The mini-pill is almost never used. It's so weak, you have to take it at exactly the same time every day." Still, neither Health Canada nor the SOGC were able to explain exactly why the pill is known to be safe.

"I personally don't know anything about the research myself -- you would want to contact the manufacturer for that information because I believe it is proprietary; it is confidential business information," said a Health Canada spokesperson. Paladin Labs was indicated to be the source for that information.

"It doesn't cause more side effects than the ordinary contraceptive pill," said a SOGC spokesperson. "It's not a medication that is potent, it's a very safe medication-we don't know the pharmacology issues on it, we just know the medication is safe-and it's been tested and it's been proven safe." The SOGC indicated "the company that does the testing," that is, Paladin Labs, as the source of study information.

However, Paladin Labs is merely the Canadian distributor of the drug, and a spokesperson was only able to refer to a study carried out by the World Health Organization in 1998 that compared the effectiveness of Plan B and the Yuzpe regimen in terms of pregnancy prevention and side effects. The mean age of participants in the study was 27. Study information on the European manufacturer's website also consists of a reference to the WHO study.

Safety is a concern especially for repeat users of the ECP. Repeat users have been noted by pharmacists in the Sunnybrook pilot study.

As some proponents point out, the risks of pregnancy and abortion are much higher for most women than the risks associated with taking the ECP. But as far as getting clients to go on regular contraception, "There are some high-risk populations that you're never going to get through to no matter how you try," said Robinson. And couples who rely exclusively on condoms for contraception are more likely to be repeat users, because condoms break, Kearney says.

However, the side effects and the emotional issues experienced by Patrick and Wilkes are for them powerful deterrents against repeat use. Patrick says she will not take the ECP again. "I would avoid it like the plague," said Wilkes.