The Morning After Pill - Health Canada proposes non-prescription status for 'morning after' pill

Health Canada proposes
non-prescription status for 'morning after' pill

Canadian Women's Health Network applauds move, but says it is not enough
'Over the counter' access to emergency contraception essential

May 18, 2004

Levonorgestrel, commonly known as "the morning after pill" or "Plan B," is an emergency hormonal contraceptive (EC) that can be used up to 72 hours after unprotected intercourse to reduce the possibility of pregnancy. To date, levonorgestrel has been only available in most provinces with a doctor's prescription. But at long last, all women in Canada may have easier access to this important emergency contraceptive.

Health Minister Pierre Pettigrew announced today that Health Canada will move forward with its proposal to change the regulatory status of EC from a prescription drug to "Schedule II status" as a non-prescription product. This means that emergency contraception would be available in pharmacies without requiring a visit to the doctor or a doctor's prescription. This is also referred to as "behind the counter" status.

The Canadian Women's Health Network (CWHN) strongly endorses changing the status of EC from a prescription
to a non-prescription product. However, the CWHN also urges that measures be taken to ensure equitable access
to EC by making it available "over-the-counter" *without pharmacist assistance.*

According to Madeline Boscoe, Executive Director of the Canadian Women's Health Network the proposed change
is not good enough. "There is no compelling medical argument to require contact with the pharmacist to obtain emergency contraception. Schedule II status for emergency contraception will create needless barriers for Canadian women by increasing costs and reducing women's privacy."

The World Health Organization and other professional organizations recognize that EC is medically safe and requires no physical assessment, and that the dosage is the same for all women.

Abby Lippman, Co-chair of the Canadian Women's Health Network, and Professor of Epidemiology at McGill
University says that "so long as credible information about emergency contraception is provided at the point of sale, in plain language with accompanying pictures, and in a variety of languages, there is no need for pharmacist intervention."

The CWHN also wants Health Canada to take measures to ensure that the change from prescription to Schedule II status does not shift the costs for EC to individual girls and women. "For emergency contraception to be available equally to all women in Canada it has to be inexpensive and easy to access. Schedule II status only bring us half way there," says Lippman.

MONTREAL and OTTAWA -- Canadian women will soon be able to purchase the so-called morning-after pill in pharmacies without a doctor's prescription, the federal Health Minister announced yesterday.

"Women facing an emergency need timely access to this type of therapy," Pierre Pettigrew said in announcing the change in the drug's status.

The move -- which stands in stark contrast to a recent decision by U.S. regulators to limit access -- was immediately condemned as politically motivated, and viewed by anti-abortion MPs as a grenade tossed into the looming election campaign.

"All you're doing, once again, is saying you can murder a child," said Elsie Wayne, a departing Conservative MP.

Health advocates, for their part, criticized the move as a half-measure, saying the government was not fully respecting a woman's right to reproductive and contraceptive choice.

That is because women will not be able to buy the morning-after pill directly off the shelf of a local pharmacy, they will first have to consult a pharmacist.

Levonorgestrol, which is sold under the brand name Plan B, is a synthetic version of the female sex hormone progesterone.

The drug is currently available in pharmacies in British Columbia, Quebec, and Saskatchewan, and with a doctor's prescription in other provinces.

Plan B works exactly like a birth control pill, but after intercourse. It capitalizes on the fact that conception does not occur immediately after ejaculation; it takes up to 24 hours for an egg to be fertilized and several more days to make the perilous trip into the uterus and latch on. The hormones in the pill make the uterus inhospitable.

Emergency contraception is not an abortion pill. (RU-486, the so-called abortion pill, is not available in Canada.) To be effective, Plan B must be taken within the first 72 hours after unprotected intercourse or a contraceptive failure, but the drug works best when taken earliest. As a prescription drug, access was not always available in a timely manner.

Plan B, which is marketed in Canada by Paladin Labs Inc., costs about $25 (plus another $20 or so for the pharmacists' consultation fee).

Women could soon have easier access to the "morning after" pill as Health Canada moves to make the drug available at pharmacies without a prescription.

The pill, known as Plan B, costs between $15 and $30. It is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering transport of sperm and/or eggs through the fallopian tubes). In addition, it may prevent an egg from attaching to the uterine wall.

Plan B is strictly a contraceptive and cannot terminate an established pregnancy.

The morning-after pill, technically known as levonorgestrel, is already available without prescription in Saskatchewan, Quebec and British Columbia.

Under Health Canada's proposal announced yesterday, women across the country could ask their pharmacist for the drug rather than their doctor, making it easier to get the drug on weekends and overnight, when most doctors' offices are closed.

The proposal to make the morning-after pill more easily available won't become law for several months while Health Canada gathers input from interested parties.

Studies show Plan B is effective at preventing almost 90 per cent of unplanned pregnancies if taken within 72 hours of unprotected sex.

A pilot project making the pill available behind the counter in 40 Toronto pharmacies two years ago and found that 7,000 women asked for the drug.

Morning-after pill will be available without prescription across Canada

Tue, 18 May 2004

OTTAWA - Health Canada is moving to make the morning-after birth control pill available without a prescription in every part of the country.

To work, levonorgestrel, commonly called the morning-after pill, must be taken within 72 hours of intercourse. If used correctly, emergency contraception can cut the risk of pregnancy by as much as 89 per cent.

"Women facing an emergency need timely access to this type of therapy," Health Minister Pierre Pettigrew said in a statement Tuesday. "Making the drug available in pharmacies without a prescription will help women to prevent unwanted pregnancies."

British Columbia, Quebec and Saskatchewan already allow women to receive the emergency contraceptive directly from a pharmacist. Women in other provinces say they aren't always able to get a prescription soon enough, especially on weekends and holidays.

Under a proposed change to Canada's drug regulations, pharmacists would be allowed to sell a 0.75 milligram dose of the emergency contraceptive. Women will have to ask a pharmacist for the drug, but won't need a prescription.

Some women's health advocates are disappointed the drug won't be available over-the-counter like cold remedies.

"There are still barriers to a woman having access to the drug if she has to go through a pharmacist to have it," said Abby Lippman, co-chair of the Canadian Women's Health Network.

Emergency contraception uses the same hormones to prevent pregnancy as the ones used in regular birth control pills. It is not the same as the drug RU-486 which ends pregnancy.

"It prevents you from ovulating if you haven't already done so," said nurse Gail Neville of Planned Parenthood in Halifax. "It changes the lining of the uterus so that a fertilized egg would not be able to implant itself."

Two weeks ago, the U.S. Food and Drug Agency rejected an application to make emergency contraception available over-the-counter, saying there wasn't enough evidence the drug could be used safely by girls under 16.

"It further encourages risk-taking behavior and sexually transmitted diseases are going through the roof," said Dr. Delores Doherty of Canadian Physicians for Life in St. John's, Nfld.

Barring a change of government, Health Canada said the pills should be available from pharmacists in four to six months.

Health Canada is moving ahead with plans to make the morning-after-pill available without a prescription, but it may still require consultation with a pharmacist before purchase.

By doing so, women would get more timely access to emergency contraceptives, Health Minister Pierre Pettigrew said in a statement.

"Making the drug available in pharmacies without a prescription will help women to prevent unwanted pregnancies," he said.

The morning-after-pill, also known as levonorgestrel, must be taken within 72 hours after unprotected intercourse, to prevent a pregnancy. But it is not always available by prescription within that time period, especially with weekends and holidays.

Health Canada plans to amend the Food the Drug Regulations to remove the pill from a list of drugs needing a prescription, to a "Schedule II" status, which requires input from pharmacists at the point of sale.

Provincial and territorial pharmacy regulatory authorities will hold consultations after that to decide on the conditions of the sale. Such consultations are normal after proposed regulatory amendments.

"The fact that the drug would be available 'behind the counter' means that women would have timely access to the drug and receive professional health advice regarding its use," added Pettigrew.

The Canadian Women’s Health Network endorses making the morning-after-pill a non-prescription medication, but says getting women to talk to pharmacists first creates a barrier.

In a message on its website, the network says that as long as credible information is available about the pill at the point of sale, with pictures in a variety of languages, "there is no need for pharmacist intervention."

Several provinces allow for the sale of the morning-after-pill without a prescription, including British Columbia, Quebec and Saskatchewan.

The World Health Organization has deemed the morning-after-pill to be safe for use without prescription. At least 28 countries have listed it as such. That doesn't include the United States.

Earlier this month, the U.S. Food and Drug Administration rejected making the morning-after-pill available over the counter, citing concerns about young teenagers' use of emergency contraception without a doctor's guidance.

The decision was made despite an earlier ruling in December by FDA's scientific panel, which voted 23-4 that providing the morning-after-pill without a prescription would be a safe and good way to prevent unwanted pregnancies.

Regardless, five states -- California, Washington, Alaska, Hawaii and New Mexico -- allow women to buy the pill from certain pharmacists without a prescription.

In the United Kingdom, a large grocery store chain by the name of Tesco plans to hand out the pills for free as part of an effort to reduce the number of teen pregnancies.

The morning-after-pill is a higher dose of normal contraception. It can cut a woman's chances of getting pregnant by up to 89 per cent. It has no effect if a woman is already pregnant.

OTTAWA -- Ottawa is making it easier for drugstores across Canada to provide the morning-after pill -- a kind of retroactive birth control -- without a prescription. Yesterday's announcement comes just days before a federal election call, prompting the Opposition Conservative health critic to complain the Liberals are playing politics with women's health.

Anti-abortion activists also denounced the move to make the pill available from pharmacists on request.

Health Minister Pierre Pettigrew said he's simply trying to help women across Canada avoid unwanted pregnancies.

The morning-after pill, technically known as levonorgestrel, is already available without prescription in Saskatchewan, Quebec and B.C.

The pill won't work if the user is already pregnant. But if ingested within 72 hours of unprotected sex, it blocks pregnancy.

The federal decision doesn't require other provinces to make the pill available upon request by women. But it makes it easier for them to do so.

Provinces that have already made the pill available without prescription had to change provincial regulations to override the federal regulations, sometimes a complicated process.

But by amending the federal Food and Drug Regulations to remove levonorgestrel from medications requiring prescriptions, provinces can rely on that to justifying making the pill available on request from a pharmacist.

The Government of Canada announced today that it will move forward with a plan to allow over-the-counter access to Plan B, commonly referred to as the "morning after pill".

"Women facing an emergency need timely access to this type of therapy," said Health Minister Minister Pettigrew. "Making the drug available in pharmacies without a prescription will help women to prevent unwanted pregnancies. "

Levonorgestrel (Plan B) must be taken within the first 72 hours to be effective. At this point, the morning after pill is only available with a prescription. By removing the prescription requirement, the ability to gain quick access to the pill will increase its effectiveness.

Even without the prescription requirement, access to the pill will require "professional intervention from the pharmacist ". Meaning a consultation with a pharmacist will be required to gain access to the pill.

"The fact that the drug would be available 'behind the counter' means that women would have timely access to the drug and receive professional health advice regarding its use," added the Minister.

Last week Health Talk reported on a decision by America's FDA that denied women over-the-counter access to emergency contraception. That decision prompted lobby groups and some members of Congress to call for the resignations of some officials at the FDA. The decision to deny over the counter access in the United States is being viewed as a "political decision".

Health Canada announced Tuesday that it plans to move forward with a proposal to change the "morning-after" birth control pill from a prescription to a non-prescription drug. That means women would be able to get the emergency contraception from pharmacies without having to see their doctor or getting a prescription.

But the Canadian Women's Health Network (CWHN) said the move doesn't go far enough. The group wants the "morning-after" pill to be available to women as an over-the-counter product, without the need for a pharmacist's assistance.

Having to deal with a pharmacist to get the pill will create needless barriers for women by increasing costs and reducing their privacy, the CWHN said.

Earlier this month, the U.S. Food and Drug Administration decided against allowing non-prescription sales of the "morning-after" pill, saying the issue required more research.

The pill, a stronger form of a traditional birth control pill, can be taken up to 72 hours after unprotected intercourse to reduce the possibility of pregnancy.

Canada has moved to make the morning after birth control pill available without prescription country-wide.

The pill prevents pregnancy if taken within 72 hours of unprotected sex and Health Minister Pierre Pettigrew says the Government's move would provide timely help to women facing an emergency.

A public consultation period about the Government changes to regulations will be held before the pills go on sale over the counter.

The morning after pill, technically known as Levonorgestrel, is already available prescription-free in Canadian provinces British Columbia, Saskatchewan and Quebec, in Australia and across parts of Europe.

But the Canadian move comes just 10 days after the US Food and Drug Administration (FDA) refused to approve over-the-counter sales of morning after pills.

The FDA says there is insufficient data on the pill's use by girls under 16 without a doctor's supervision, but political opponents charged with administration with putting politics before science.

OTTAWA (AP) - The Canadian government announced plans Tuesday to make the morning after birth control pill more widely available without a prescription.

Health Minister Pierre Pettigrew said the change would give timely access to emergency contraceptives for women and help prevent unwanted pregnancies.

The move comes weeks after the U.S. Food and Drug Administration decided to keep the pill on its list of prescription drugs.

Anti-abortion activists have denounced Canada's decision, which won't become law for several months while the health department reviews the issue gathers input from interested parties.

``We're not talking here about reopening a debate'' about abortion, Pettigrew said from Geneva, where he's attending a World Health Organization meeting.

If taken within 72 hours of intercourse, the pill blocks pregnancy. But it won't work if the user is already pregnant.

The pill is already available without prescription in Saskatchewan, Quebec and British Columbia.

The federal decision wouldn't require the remaining provinces to make the pill available, but would make it easier for them to do so, officials said.

TORONTO, May 18 - The government proposed on Tuesday to allow women to obtain the so-called morning-after birth control pill without a prescription at any pharmacy in Canada.

The proposal needs to go through a review by Health Canada, the chief medical regulatory agency, but it is expected to meet final approval in the next few months.

The move comes only weeks after the acting director of the Food and Drug Administration in the United States declined to allow the morning-after pill to be sold without a prescription.

The latest divergence in American and Canadian social policy - the two governments have also gone in different directions on drug enforcement and same-sex marriages - is likely to result in many American women crossing the border to obtain the pills.

"Women facing an emergency need timely access to this type of therapy," Health Minister Pierre Pettigrew said in a statement. "Making the drug available in pharmacies without a prescription will help women to prevent unwanted pregnancies."

Women in Quebec, Saskatchewan and British Columbia can already buy the pill without a prescription simply by consulting a pharmacist. The proposed amendment to the Canadian Food and Drug Regulations would expand that availability across the country. It would be left to the provinces to decide at which age women could obtain the drug.

Mr. Pettigrew said he was satisfied that women would still "receive professional health advice" before using the pills because they would be required to consult a pharmacist. He said the drug would be available "behind the counter" rather than "over the counter."

The morning-after pill contains a strong dose of the contraceptive levonorgestrel, which impedes ovulation. If taken within 72 hours of having sex, the pill can prevent a fertilized egg from being implanted. Mr. Pettigrew's announcement came only days before Prime Minister Paul Martin was expected to call a national election for late next month. Women's groups and birth control advocacy agencies applauded the announcement, but the conservative opposition criticized it.

Rob Merrifield, a Conservative member of the House of Commons who specializes in health affairs, said the new policy could endanger public health. "This drug is 50 times as potent as a birth control pill, and we're treating it like an aspirin," he said.

He added that the announcement was totally politically motivated and intended to make the conservative opposition look extremist.

"They laid it out there knowing it's a volatile issue, and they wanted someone to fall into a trap and to say something controversial," he said.

TORONTO -- The government proposed Tuesday to allow women to obtain the "morning after" birth-control pill without a prescription at any pharmacy in Canada.

The proposal needs to go through a review by Health Canada, the chief medical regulatory agency, but it is expected to win final approval in the next few months.

Health Minister Pierre Pettigrew said he was satisfied that women would still "receive professional health advice" before using the pills because they would be required to consult with a pharmacist. He said the drug would be available "behind the counter" rather than "over the counter."

If taken within 72 hours of having sex, the morning-after pill can prevent a fertilized egg from being implanted.

Rob Merrifield, a Conservative member of the House of Commons who specializes in health affairs, said the new policy could endanger public health. "This drug is 50 times as potent as a birth control pill and we're treating it like an aspirin," he said.

Canada to Allow Broad Access to Morning-After Pill

Tue 18 May, 2004

OTTAWA (Reuters) - The Canadian government proposed on Tuesday granting access without prescription to the "morning-after pill," hailed by feminists as emergency contraception but condemned by abortion opponents as destroying life.

The drug must be taken within 72 hours of intercourse to be effective but controversy surrounds exactly what it does -- and consequently whether it acts like an abortion.

Campaign Life Coalition calls it an abortifacient, saying it prevents a fertilized egg from implanting in the mother's womb and therefore causes it to be expelled.

"Obviously Mr. Pettigrew's not concerned about the women who are taking these powerful cocktails and he's not concerned about the baby whose life is going to be lost," spokeswoman Mary Ellen Douglas said.

A similar squabble has gone on in the United States, where the U.S. Food and Drug Administration has denied Barr Pharmaceutical Inc.'s bid to make over-the-counter sales of the morning-after pill.

Forty-one members of Congress sent a letter last week urging the FDA to reconsider.

In Canada, where abortions are legal and considered a medical procedure, pharmaceutical regulatory authorities are recommending that the pill be available "behind the counter," meaning that a customer would have to talk to a pharmacist but would not need a prescription.

The morning-after pill may soon be available over the counter at your drug store.

The Federal Minister of Health Pierre Pettigrew is proposing an amendment to the Food and Drug Regulations to permit the non-prescribed sale of the so-called emergency contraceptive.

The drug must be taken within 72 hours of unprotected sex or a contraceptive accident.

It's argued immediate access to the drug is a must otherwise it's too late to prevent a pregnancy.

Ottawa, ON, May. 18 (UPI) -- Canada's health minister Tuesday proposed making the morning-after pill available over the counter across the country.

Health Minister Pierre Pettigrew has proposed amending the Food and Drug Regulations to permit a 0.75 mg dose of levonorgestrel to be available without a doctor's prescription, the Globe and Mail reported.

"The fact that the drug would be available 'behind the counter' means that women would have timely access to the drug and receive professional health advice regarding its use," Pettigrew said in a statement.

The emergency contraceptive, which must be taken within 72 hours after intercourse, is currently available through prescriptions and at certain clinics, making it difficult at times to access within the recommended timeframe.

The proposed amendment will be subject to a consultation period, which is standard for regulatory amendments.

Ottawa making morning-after pill available without prescription

by SANDRA CORDON
Canadian Press
Tuesday, May 18, 2004

OTTAWA (CP) - Ottawa is making it easier for drugstores across Canada to provide the morning-after pill - a kind of retroactive birth control - without a prescription.

Tuesday's announcement comes just days before a federal election call, prompting the Opposition Conservative health critic to complain the Liberals are playing politics with women's health. Anti-abortion activists also denounced the move to make the pill available from pharmacists on request.

Health Minister Pierre Pettigrew said he's simply trying to help women across Canada avoid unwanted pregnancies.

And he insisted it's a government decision rather than a Liberal policy announcement.

"We're not talking here about reopening a debate" about abortion, Pettigrew said from Geneva, where he's attending a World Health Organization meeting.

"It is not an abortion and that is why I've kept a very governmental approach to this," he added.

"We're doing this to help women, often younger women, who are facing difficult circumstances sometimes at a moment when they're trying to build a life for themselves in the future."

It's widely expected that this Sunday, Prime Minister Paul Martin will call a federal vote for June 28.

Health care is likely to dominate the agenda and it seems a key Liberal strategy will be painting the Conservative party as an extremist right-wing movement.

Rob Merrifield, Conservative health critic, said the Liberals are using the morning-after pill issue to try to provoke a heated debate on a touchy moral issue.

"It's politically motivated . . . it's unfortunate they continue to play politics with health care," Merrifield said from Edson in western Alberta.

"He's trying to get other parties to react in a negative way to put them in an awkward spot . . . to paint others as extremist."

The proposal to make the morning-after pill more easily available won't become law for several months while Health Canada gathers input from interested parties.

The morning-after pill, technically known as levonorgestrel, is already available without prescription in Saskatchewan, Quebec and British Columbia.

The pill doesn't induce an abortion and won't work if the user is already pregnant.

The federal decision doesn't require other provinces to make the pill available upon request by women. But it makes it easier for them to do so, says a federal Health official.

Provinces that have already made the pill available without prescription had to change their provincial regulations to override the federal regulations, sometimes a complicated process.

But by amending the federal Food and Drug Regulations to remove levonogestrel from a list of medications requiring prescriptions, provinces can now simply rely on that to justifying making the pill available on request from a pharmacist.

Ottawa has erred in making a pill designed to prevent pregnancy more readily available, says the Campaign Life Coalition.

"Has this government gone mad?" Jim Hughes, coalition national president, said in a statement.

Ottawa's move comes only a few weeks after the United States took the opposite course.

The U.S. Food and Drug Administration decided to keep it on their list of prescription drugs, citing concerns pharmacists might give the drug to young women under 16.