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The morning after the morning after (or, what the FDA decision about Plan B means to you)

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Submitted by Heather Corinna on Wed, 2006-09-06 16:00

The morning after pill is now legal in the U.S. for over-the counter use, without a prescription, for those over 18.

But what does that mean to you?

Following is an in-depth question and answer page about the decision and how it will be applied for all women, about Plan B, and about pharmacist refusals and how to manage them. Please circulate this information and/or link it as widely as possible, (with attribution to the author, please).

The FDA press release from the day of the decision stated:

"The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.
Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:

  • Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;
  • Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;
  • Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and
  • Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18."

Will Plan B just be on the shelf like aspirin?
No. Plan B/the Morning After Pill (MAP) will be kept behind the counter in pharmacies, and a consumer purchasing it will be required to provide valid identification showing they are over the age of 18. Those under the age of 18 will still need a prescription to obtain Plan B.

What will it cost?
Barr Pharmeceuticals has stated that the current cost -- around $25-$40 -- will likely increase for over the counter sales and for Plan B obtained by prescription, largely due to packaging changes. They have not stated by how much. For those who are insured or on medicaid, they will likely be able to have most of their costs of EC (emergency contraception) covered with a small copayment for the medication.

Can someone over 18 legally get it for someone under 18?
The FDA heads have compared sales of Plan B to the way sales of alcohol, cigarattes and nicotene replacement products go (we know, it's crazy to treat birth control as contraband: boy, do we know). At this time it is safe to assume that an adult purchasing Plan B for a minor would be treated legally the same way an adult purchasing alcohol for a minor would, in that it likely WILL be a criminal offense. However, some people have already publicly stated that they intend to engage in doing so as an act of civil disobedience.

9.21 Update: The Princeton Emeregency Contraception site has just added the following to their informational page on over-the-counter EC status: "Dr. Galson said that the FDA is not in the business of regulating the practice of medicine or individual people's behavior as regards drug use. There are no restrictions against a person 18 or older buying the product in advance to have on hand for future use. There are no restrictions against a person 18 or older buying multiple packages of Plan B at one time. Opponents of the age restriction have noted that it will be much easier for young women to get an older friend or relative to buy Plan B for them than to get a doctor's prescription (and cheaper, too)."

In other words, the FDA seems to be stating that those over 18 buying Plan B for those under 18 is simply not the business of the FDA. The FDA has NOT, however, stated it is lawful for a person to do so.

But what if my boyfriend is over 18?
Maybe. The makers of Plan B did not seek out approval for sales of the MAP to men, by prescription OR over the counter. As well, since the wording on most policies state identification needs be provided to show the consumer of the medication to be over 18, it's hard to decipher how things would work if a male was purchasing EC for a woman, and if consumer is defined as actual user or as purchaser.

However, there does not thus appear to be policy which clearly bars men from purchasing EC OTC, either. Likely, you will need to reference the specific policies of the pharmacy board for your state (of course, if you've a male partner who wants to try to get it for you, he could also just give it a shot and see what happens: however, given that timing is critical, it would likely be most sound just to get it yourself.)

9.21 Update: Dr. Galson of the FDA has now also stated in a press conference that men over the age of 18 can lawfully obtain over-the-counter Plan B as well. However, to avoid delays, it would be advisable to call the pharmacy you intend to go to in advance and ask about this, especially given the troubles even women are having with pharmacy refusals.

How does Plan B work again? Is it abortion?
Plan B is CONTRACEPTION (birth control). It works just like other methods of contraception do, by preventing pregnancy. The morning-after pill does not have the capacity to terminate an existing pregnancy, only to prevent one: it will not work if a woman has already become pregnant. While some who would like to keep women from being able to access Plan B have stated it resembles abortion, this is an untruth. Even the information from the FDA's press information on this change in Plan B status makes clear that is it contraception:

"Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work. "

In case this is unclear, remember that pregnancy is not instantaneous: it does not occur immediately after a risk, but takes around 6-8 days to occur, which is why EC can work as it does to prevent pregnancy.

Plan B needs to be taken within 120 hours of a risk, and the sooner it is taken, the greater its effectiveness is. So, ideally, you will want to obtain EC if you need it as soon as you know you have had a risk. It can be helpful, for this reason, to either purchase Plan B over-the-counter if you are 18 and up in advance, or to ask your doctor or gynecologist for a prescription to fill, just to have on hand in case of a risk/birth control failure.

If you suspect you are pregnant, Plan B will NOT work to terminate a pregnancy. Unfortunately, some of those opposed to Plan B who have tried to intentionally misrepresent it stating it is abortion have acheived their end in some respects by confusing an awful lot of women.

If you wish to terminate a pregnancy, given the limited time window in which a termination can be done, it is useless to try and use Plan B/The MAP in hopes it will be a cheaper, easier way to do so. It cannot accomplish this end. If you suspect you are pregnant and think or know you may wish to terminate, you need to speak to an abortion provider about medical or surgical abortion.

Will it EVER be available over the counter to women under 18 in the States?
We sure hope so, and Scarleteen as an organization strongly feels it SHOULD be available to women of reproductive age under 18. We feel the only reason it is not is not due to medical or practical concerns, but to political agendas and a strong desire for those in power to control women's lives, and usurp women's rights to ownership of their/our own bodies.

It is in other countries, and obstetricians and gynecologists support that there is NO medical or practical reason we currently know of which would provide sound cause NOT to provide EC over the counter for women not yet 18. In fact, the American College of Obstetricians and Gynecologists very directly expressed strong objections to the age limit in this statement here, in which they said,

"In light of the US Food and Drug Administration's (FDA) decision to approve over-the-counter (OTC) status for Plan B, emergency contraception (EC) for women age 18 and older, The American College of Obstetricians and Gynecologists (ACOG) today emphasized the need for unimpeded access to EC for all women of reproductive age. Timely access to emergency contraception is pivotal in reducing the number of unintended pregnancies and abortions in the US. By restricting its OTC availability to women age 18 and older, the FDA has missed an unparalleled opportunity to prevent teenage pregnancies. Each year there are more than 800,000 teen pregnancies in the US, with many ending in abortion. Pregnancy itself is not without risk, especially for a young woman. There is no scientific or medical reason to impose an age restriction and to withhold EC from this population. EC is safe for over-the-counter use by women of all ages."

The Kaiser Network's report on recent developments with EC access adds that the "Center for Reproductive Rights lead attorney Simon Heller said the group will continue with its lawsuit against FDA over its rejection of Barr's first application for nonprescription Plan B sales, the Tribune reports. CRR -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed the suit in a U.S. District Court in New York, claiming the agency did not follow procedure when it denied the original nonprescription Plan B application. In a deposition in the case, John Jenkins, director of FDA's Office of New Drugs, said that Galson told him "that he felt he didn't have a choice" but to reject Barr's original application. Jenkins added that Galson "characterized that in a sense that he wasn't sure that he would be allowed to remain as center director if he didn't agree with the action". Heller said that CRR will seek to have the age restriction for nonprescription Plan B sales overturned through the lawsuit."

The FDA stated its reasons for not making it available over-the-counter to women under 18 so to be these: "because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable."

Given that there is no difference between women's bodies in general at the age of 18 and the age of 17 (though for two given women at that age, or at 18 and 21, for that matter, their development may differ), and given the FDA already found that it could be safe to sell to those 17 and older, with continued lobbying, this may not be all that challenging to refute and disprove. Data from other countries on long-term effects of Plan B for adolescent women who have been using it OTC for some time may be of use in doing this, as that data is available, and thus far, there is nothing to my knowledge which shows ill effects of Plan B in women under 18 as a whole. Undoubtedly, SOME age limit will be put on this even if the age limit is changed, which may be sound, given that in women of considerably younger ages, it's not unsound to presume that EC, like other hormonal medications, may have side effects in far younger women which would not be as prevalent in older teens and adult women.

FDA Commissioner Eschenbach listed some other reasons in his own memo for making the age 18, such as that since 18 is the legal age for purchasing cigarettes, it would be easiest for pharmacists to remember. This and other "management issues" are being argued against, for obvious reasons.

So, a woman over 18 can just get it anywhere?
Not quite, and not just yet.

The makers of Plan B still have to provide new packaging, and all of the loose ends need to be tied up with this new decision. But very soon, women 18 and over should be able to purchase Plan B without a prescription at any pharmacy. According to the Kaiser Health Network, US pharmacy chains CVS and Walgreens anticipate sales beginning in their stores in October or November, as soon as the new packaging is provided. Wal-Mart has stated that it has not yet decided if it will sell Plan B over the counter, and have had a longstanding ban through all their stores which prohibits even pharmacists who WANT to fill Plan B prescriptions to do so.

(And when Plan B is available over the counter, we'd urge you to make a point of not supporting pharmacy chains who do not sell Plan B, for any purchases, and informing them via email, post or active protest, as to why you will not shop there. Consumer pressure is often is a very effective way of influencing companies. Supply, demand...you know the drill.)

As well, Planned Parenthood and other clinics will continue to help women above and below the age of majority acquire Plan B.

Per getting it everywhere? Well...there's the $60,000 question.

First of all, it won't be available at gas stations or mini-marts. You'll need to go to a pharmacy or a store with a pharmacy in it.

The bigger issue is that right now, there is a giant fracas among some pharmacists, the states they work in, and the pharmacy boards of each state about whether or not a pharmacist has the right to refuse to sell Plan B, both over the counter and when sold by prescription. Some pharmacists state that they morally object to Plan B because they consider it to be abortion, or "too close" to abortion, even though it works the same way birth control pills and other methods of contraception work; even though Plan B cannot terminate a pregnancy.

In April of 2005, a bill was put forth to congress which would lawfully allow pharmacists in the US -- despite the conflicts with the state board codes pharmacists are to adhere to via the refusals, which are generally only to occur if and when a pharmacist feels a medication may cause potential PHYSICAL harm to a patient, such as via dangerous drug interactions or dosage errors -- to "refuse to fill valid prescriptions for drugs or devices on the basis of personal beliefs, and for other purposes, " called the "Access to Legal Pharmaceuticals Act."

The congressional findings were that:

  • (1) An individual's right to religious belief and worship is a protected, fundamental right in the United States.
  • (2) An individual's right to access legal contraception is a protected, fundamental right in the United States.
  • (3) An individual's right to religious belief and worship cannot impede an individual's access to legal prescriptions, including contraception.

This resolved with the decision that if a given pharmacist refused to fill a prescription or provide an over-the-counter drug, that another pharmacist must provide it. If the product is not in stock, or a pharmacist refuses to stock it, the pharmacy must have another pharmacist order and supply the product. A penalty of $5,000 per day of violation. However, different states have different laws.

As well, the National Women's Law Center reports that, " The American Pharmacists Association (APhA) states: APhA recognizes the individual pharmacist's right to exercise conscientious refusal and supports the establishment of systems to ensure patient's access to legally prescribed therapy without compromising the pharmacist's right of conscientious refusal.

This policy has been interpreted by the APhA to require a pharmacist to refer to another pharmacist a prescription that he or she refuses to fill on grounds of conscience. The organization notes that the patient should not have any awareness that the pharmacist was refusing to fill the prescription. When the profession's policy is implemented correctly -- and proactively -- it is seamless to the patient, and the patient is not aware that the pharmacist is stepping away from the situation. Whether another pharmacist on duty completes the prescription or patients are proactively directed to pharmacies where certain therapy is available, or even different systems are set up, the patient gets the medication, and the pharmacist steps away from that activity, with no intersection between the two."

This means that pharmacists who are actively and publicly (or to the patient) stating they will NOT provide EC ARE in violation of that code and how it is to be implemented.

Here's a factsheet from the NWLC on pharmacy refusal and the law, and if you're curious, here is the APhA's general code of ethics for pharmacists.

The NWLC factsheet outlines how some of these policies work, as well as several grounds for refusals being unlawful, such as via sexual discrimination (if the only refusals are to prescriptions, such as EC and other forms of contraception, taken by women, it is sexual discrimination).

On top of all of that, different pharmacies and chains have their own policies on this issue, too.

You can see that all of this is very tangled and incredibly confusing. Some of why is because most of these refusals are very much ONLY applied to contraception and/or emergency contraception and to women. These pharmacists are not refusing other patients medications, nor are their personal feelings and/or religious or personal morals often being applied in other areas. For that reason, everyone is being very shirty about the issue, likely to avoid lawsuits and loss of their jobs based on clear sexual discrimination. For that reason, many pharmacists refusing are stating the refusal to be on religious grounds, even if it is not in fact the case, and even if they are not refusing other methods of contraception on those same grounds, which is clearly hypocritical, illogical, sexist and often simply willfully ignorant.

Suffice it to say, it will likely take some time for clearer, broader policies, both in states and federally, and via professional boards for pharmacists and pharmacies, to be sorted out. Unfortunately, it is anticipated that the rates of refusal will continue to increase as more women become aware of Plan B and more women request it.

So, what should I do if my prescription is refused, or if I am over 18 and a pharmacy will not sell me EC over the counter?
You have several options.

First, you may and should demand that another pharmacist fills your prescription or provides you with EC over the counter if you are 18 or over. If the pharmacist refuses to ask someone else, you can ask to speak to a manager and inform them of the required transfer policy.

If that pharmacy refuses outright, you may request they have another pharmacy send the EC to your home via an express shipping agency (at their expense), or that they call into another local pharmacy for your prescription where you can pick it up there.

You can send a letter to your state representative, and to the pharmacy itself, as well as the pharmacy board of your state. If it is a corporate chain, send it to both the local branch you were at and to that chain's corporate HQ. If you want to take an extra stand, make a point of asking the pharmacist who refuses you for those addresses and his/her full name at the time of the refusal, and make clear you are sending a letter.

You may consult a private lawyer to determine if you have grounds for a lawsuit, if you like.

Sometimes, these refusals may turn volatile or be deeply distressing. For instance, the NWLC listed examples of refusals in this document, including a mother of six in Wisconsin who was publicly and loudly called a murderer by her pharmacist in requesting EC, and a rape survivor in Texas who was refused by three different pharmacies.

So, when deciding what to do, be sure and take care of yourself AND think in your best interest. If you feel up to making a big stand, that's great. But if you'd feel better going to get a friend first, do. If you're just upset enough as it is, let it go, write letters later when you feel up to it. And if making a stand right there and then will put you at risk of not getting EC in time, get the EC first elsewhere, deal with the refusal activism later.

What else can you do?
Report a Plan B/MAP refusal to us here at Scarleteen, whether you are over 18 and it was refused OTC, or you are any age and a phramcist refused to fill your prescription for emergency contraception. You can report via the comments in this blog entry or by email (you can get it to me at planc @ heathercorinna.com). We'll compile and post a list to out pharmacists and pharmacies refusing EC to women, and it'd be helpful to all women in the states to know where NOT to go when they need EC, especially given that getting it in a timely manner is so important.

I have also arranged with a lawyer at the ACLU for us to forward these reports to them so that they may compile them for possible future legal action against these pharmacies and pharmacists and/or state laws which allow for these refusals. When you report, just make sure we have contact information for you (an email address will suffice), and the details of the refusal: who refused, by name, at what pharmacy where, and a brief summary of what happened. You may also call your local Planned Parenthood and ACLU chapter to report the refusal directly.

You can also write letters to your state representatives about both pharmacy refusal issues and/or about why you think it is not sound to refuse younger women access to Plan B over the counter. If you have a school or university newspaper, send in a letter or editorial. Write an op-ed piece or letter to your local city or town newspapers. Actively protest pharmacists, pharmacies or chains which refuse to fill EC prescriptions or provide it over-the-counter. Refuse to shop from them for anything, organize a street protest, what have you. Step up and speak out.

Some extra links for more information:

Two pieces at Scarleteen about Emergency Contraception:

- Heather Corinna, Founder & Editor, Scarleteen.com

(Updates added as of September 21st, 2006)

Comments

FOR EVERYONE UNDER 18 YEARS OF AGE

Mon, 2009-04-27 14:49
Anonymous

Hello all. I love this website so thank you for all of the great info. I just wanted to post the following:

In the United States women 18 and older can get EC at pharmacies without a prescription. For teens under the age of 18, EC may require a prescription depending upon the state; some states have a special program that allows trained pharmacists to give out EC. You may need to check many different pharmacies because EC is not available in all pharmacies. Use the EC website at http://ec.princeton.edu/index.html to find a doctor or pharmacy or call the toll free phone number 1-888-NOT-2-LATE if you have any questions about emergency contraception. Be ready to answer the following questions:

When was the first day of your last menstrual period?
When was the exact date and time of unprotected sex?
What types of birth control have you have used in the past?

This is the website where i got that from:
http://www.youngwomenshealth.org/emergency_contraception.html

I also found this:
"Teens under 18 can still get EC the old-fashioned way — with a prescription. The best way to protect yourself is to get a prescription from a health center or private health care provider before an accident happens, and keep it on hand. That way, you won't waste time waiting to get an appointment with a health care provider or trying to get your prescription filled when you need EC.

Plan B is safe, effective, and should be available to all women. But because of certain policies and the personal bias of some pharmacists, you may still have a hard time getting it. If you're having trouble getting a prescription for EC from your health care provider or getting it filled by your local pharmacy, contact your local Planned Parenthood health center." http://www.teenwire.com/

EC

Wed, 2008-08-13 15:01
may_16525

Wooh Hoo for us!

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