FDA rejects the OTC morning after pill

[ribbon]

:trigger (potentially sensitive topic - ie., emergency contraception, morning-after pill)

<HR>

FDA rejects nonprescription morning-after pill for now

LAURAN NEERGAARD, AP Medical Writer
Thursday, May sixth, MMIV




(May-sixth) PDT WASHINGTON (AP) --

The government rejected over-the-counter sales of morning-after birth control on Thursday because of concern about young teenagers' use of the pills. But regulators left open the possibility they will reconsider.

The Food and Drug Administration was under intense political pressure from both sides on whether to lift the prescription requirement for emergency contraception. Conservatives argued doing so could encourage unsafe sex. Proponents said easier access to the pills could prevent thousands of abortions -- and the FDA's own scientific advisers had overwhelmingly backed the change.

But in a letter to Barr Laboratories late Thursday, the FDA said there was no evidence teens younger than sixteen could safely use the pills without a doctor's guidance -- and it thus was rejecting the move until Barr could provide that evidence.

The FDA had told Barr about the teen concern in February, and the company proposed allowing nonprescription sales for everyone sixteen and older but requiring anyone younger to have a doctor's prescription.

Such a step, which presumably would require drugstores to check customers' ages, has never been tried. The FDA said the company didn't provide many details, making it impossible to decide if such a program would be legal and doable.

But Thursday, FDA officials left open the door for Barr to try again, telling the company exactly what information they would need to reconsider: either data showing young teens could use the pills safely without a prescription or details on how to make the mixed-marketing approach work.

"Wide availability of safe and effective contraceptives is important to public health," the FDA letter said. "We look forward to continuing to work with you if you decide to pursue either of these options."

Barr chief executive Bruce Downey said in an interview that the company would rapidly pursue one or both of those options -- even as it more actively advertises the prescription version of its morning-after brand, called Plan B, so more women know it's an option.

"It's a matter of weeks and months to deal with this objection," Downey said, saying that means the FDA could reconsider the issue within a year. "Clearly ... the door's open, and we plan to go through it."

Within the FDA, the decision was mixed. An internal agency memo, obtained by The Associated Press, suggests medical reviewers backed nonprescription sales of Barr's brand, called Plan B, but were overruled by senior officials.

"Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity," said the memo, written by FDA acting drug chief Dr. Steven Galson. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."

Galson noted that some eleven- to fourteen-year-olds are sexually active but that "despite the urgent need to prevent pregnancy in these young adolescents, the application contained no data in subjects under fourteen years of age.

The memo pledged that Galson "will be working toward the expeditious evaluation of Barr's proposed access plan when we receive a complete version."

The morning-after pill is simply a higher dose of regular hormonal contraception. Taken within seventy-two hours of intercourse, the pills cut the chances of getting pregnant by up to eighty-nine percent.

The sooner they're taken, the more effective they are. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays.

If a woman already is pregnant, morning-after pills have no effect.

I tend to believe that the reasoning is a smoke screen for the right wing anti choice folks who do not want the drug available at all.

If a child is having consentual intercourse with a peer (and I'm not sure if I believe the consentual part is possible), I would bet they are not children who have the type of parent/child relationship where they can talk to their parents to go see a doctor for the pills.

If the situation is one of abuse, I think that not becoming pregnant from incest is more imperitive than whether or not the pills given.

If this is truly about the age then why can't the druggist just sell it only to those over fourteen.

Any thoughts.

[PrettyKittie]

I personally can't help but feel that they shouldn't be done over the counter, for any age!
If there is a situation warranting the use of the morning after pill, then there is a situation that warrants discussing the matter with someone as well.
Just my two cents.

[shortstop]

Didn't the gov't just ban the sale of effedra to anyone under eighteen? I've seen the signs at my pharmacist! If they can card for that then they can card for the morning after pill. :ummm
I think that it should be sold too. I mean, really, not selling the pills isn't going to stop sex between younger teens. You're right :ribpink, these kids aren't going to be able to run to mommy if they do have unprotected sex because if there is sex that young there is another problem.
I can't believe that they didn't okay it....well, I can. I mean, they were musing about overturning Roe V Wade! :surprise :ugh :mad
So, in all...it should be an over the counter option. It's not going to stop sex, (because uh, that's going on anyway) it's only going to prevent unwanted children in unwed young and younger children.

[ItWasReal]

As you probably know, in the UK the morning after pill is available OTC. I personally think this is a good idea. In the past I have had to get it from a pharmacist and because I look young for my age, the pharmacist had to see my passport to check my age and then asked medical questions. It was bloody expensive, which is my concern because working in a young person's drop in, if they cant get to the clinic then they often cant afford to buy the pill from the chemist.

I haven't noticed amongst my peers, them al using it as a form of contraception or anything dramatic, I think it is a good idea if the pharmacist takes the necessary precautions in giving it out.

[sflathinker]

I am normally very liberal but I don't think it should be OTC. If you are old enough to have sex, you are old enough to make an appt with a doctor and get the script. Besides, I think their fears are warranted. It won't stop kids from having sex, but having it OTC makes it too easy for someone to avoid using protection knowing they can head to the store and pop a few pills to avoid pregnancy.

[battgyrll]

I don't have time to reply to this right now, but....:reallymadI'm not sure you want me to get started on this anyway:reallymad.

:bat battgyrll :bat
Sara

[ribbon]

battgyrll said: I don't have time to reply to this right now, but....:reallymadI'm not sure you want me to get started on this anyway:reallymad.

:bat battgyrll :bat
Sara

Yes I do. I tried to bump up your old post about this and couldn't find it. Your liberal buddy :ribpink.


Mara what about unconsentual sex? (I would hope they would go to the hospital and report, but if not)

[sflathinker]

We're talking about making a drug available to EVERYONE that can be purchased without a doctor's consent. Unfortunately too many drugs are mis-used and it's the FDAs responsibility to determine which drugs can be disrubuted OTC safely.

I am very happy that this drug is available at all.

[ribbon]

sflathinker said: I am very happy that this drug is available at all.

Considering this is the :usa and not europe I should probably agree with you :ohboy :muhaha.

[Jen]

Hmmm......................

Personally, (with influence and bias from my medical training I'm sure) I do NOT feel that Plan B is a safe OTC medication. Ironically at the end of April one of our conference cases although not specifically involving Plan B illustrated very nicely why this is a bad idea. I really wish that this was used as an example rather than asking that the drug be tested in younger subjects (which will probably be challenging recruitment and informed consent). So while I agree with the ultimate decision I do wish that it was arrived at in a different way perhaps.

:flowerThe Case (For those of you who are interested):flower
:bulletA forty year old female is transferred from a local hospital with chest pain and dyspnea. Labs done prior to transfer showed severe anemia and thrombocytopenia and an EKG showed new t-wave inversions (indicating cardiac ischemia). Due to inability to establish acess she was not transfused or volume resuscitated prior to transfer and was a direct admit to the ICU.

:bulletEKG on arrival showed persistent t-wave inversions in the lateral leads and no ST elevation. On exam the pt. was hypotensive and had significant bruising and petechiae, a grade III/VI systolic murmur, clear lungs, a benign abdomen without splenomegaly and vaginal bleeding. [Additional history documented soaking ten-twelve pads daily for the past eight days].

:bulletCentral access was obtained by the intensivist, oxygen administered (aspirin and anticoagulation was held due to severe thrombocytopenia) when blood was available and the peripheral smear confirmed absence of schistocytes the pt. was transfused platelets and packed cells. Vaginal bleeding persisted and an appropriate rise was not reached with transfusion. The intensivist confirmed that the pt. had never smoked, never been noted to be hypertensive, and there was no known history of blood clots or stroke in the family and decided to give estrogen to stop the bleeding (the dose used was less than half of the Plan B dose) which worked.

:bulletThe next morning the pt. was no longer bleeding, chest pain free, and EKG showed normalization of t-waves. A bone marrow biopsy was performed (which subsequently showed ITP) and the pt. continued to improve on steroids.

:bulletThe subsequent day the pt. was noted to have significant left lower extremity swelling and doppler studies confirmed a deep venous thrombosis (blood clot) [relevant note central access had been established via R Femoral V. and no evidence of clot was noted on the right]. Pt. was anticoagulated with lovenox, and echocardiogram showed no evidence of right heart strain and she was on room air with no clinical suspicion of pulmonary embolus. She was transferred out of the ICU to telemetry and observed and discharged two days later on lovenox injections to manage her DVT and steroids for ITP (PCP and GI prophylaxis with TMP-SMX and PPI). Her internist stressed to her that she will never be an OCP canidate and should use other forms of contraception.

Teaching Points From the Handout:
:bear with me this was presented by the ICU attending who was post call and the sarcasm is shall we say dripping?
:sarcasmStabilization is key--if you wish to work in a community hospital please learn how to stabilize your patients. You too can put in a central line!
:sarcasmEverything we do inherently has risks. Good physicians practice in a way that they maximize benefits and minimize risks. In this case both action (giving estrogen-->DVT risk) and inaction (persistent bleeding-->hypoperfusion state--->persistent cardiac ischemia) had risks.
:sarcasmIf your patient is competent they need to understand the risks and benefits of your plan for treatment and agree with that plan. Anything less is battery.

I realize this case wasn't selected to debate Plan B or really even the mismerits of estrogen (althoguh we did do a side lecture on that and on DVT risks etc) The presenting intensivist did believe her administration of estrogen led to the DVT but in retrospect agrees that the risks of persistent bleeding were greater. Perhaps speaking to her point about involving patients in the decision making process she did note that when she explained the DVT to the patient she commented something like "You warned me about that---but we couldn't let me keep bleeding." So although I think the point of this was to encourage us to think and inform the outcome reinforces my concerns that emergency contraception isn't a medication that we should be taking without some discussion with a physician. As I mentioned the previous time this came up if you are worried about the timing issue just discuss risks and benefits with your FP, internist, GP, Gyn etc and ask them to write you a script at that time if it would be a reasonable option for you. You can fill the script then or wait until you know you need it. This also allows some tracking (because multiple doses change the risk profile).

:peace!
:love,
Jen:bear

[battgyrll]

I'll present another scenario....

:flower It's Firday night. You go out and are having a great time at a party and from whatever circumstances, you are raped. You are not on birth control because you are not normally sexually active so you don't need it.

:flower Saturday morning you wake up and think "At least there's the morning after pill!" But it's Saturday and all your doctors offices are closed.

:flower "I'll go to the ER" you think. But your ER at your hospital doesn't offer EC because it doesn't believe in it.

:flower It's Sunday, there is nothing open today. If EC was over the counter you could go to a store and buy it. And youc ould have done that yesterday too, but you will just wait until tomorrow to go to the doctor.

:flower It's Monday. Thankfully you can go to the doctor and get your Rx and get EC and you won't have to worry about it anymore. But wait...isn't this Labor Day/Memorial Day/random three day weekend? Your doctors office is closed.

:flower Tuesday. Finally you can go to the doctor. But what if they can't get you in? What if you don't have a car and no one is available to take you to the doctor? And isn't it only effective if taken within onehundred and twenty hours? When exactly is that up?

I don't have the energy to write anymore about this right now. Obviously I left out a lot of other emotions from getting raped and never went into reasons for why this person didn't go to the hospital or the police right away, but you get the idea. I didn't want to write a short novel about it. I tried to make a point, hopefully I did.

:bat battgyrll :bat
Sara

[Kensington]

sflathinker said: If you are old enough to have sex, you are old enough to make an appt with a doctor and get the script

While I agree with that in theory, your average teenager is not in a position to make an appt. with a gyno & pay for it, & often does not have the balls (pardon the pun) to go. In an ideal world, all teenage girls having sex would see a gyno first, be on birth control, report rapes & take sex seriously as an adult would, but that's not the real world.

[Jen]

battgyrll said: I'll present another scenario....

:flower It's Firday night. You go out and are having a great time at a party and from whatever circumstances, you are raped. You are not on birth control because you are not normally sexually active so you don't need it.

:flower Saturday morning you wake up and think "At least there's the morning after pill!" But it's Saturday and all your doctors offices are closed.

:flower "I'll go to the ER" you think. But your ER at your hospital doesn't offer EC because it doesn't believe in it.

:flower It's Sunday, there is nothing open today. If EC was over the counter you could go to a store and buy it. And youc ould have done that yesterday too, but you will just wait until tomorrow to go to the doctor.

:flower It's Monday. Thankfully you can go to the doctor and get your Rx and get EC and you won't have to worry about it anymore. But wait...isn't this Labor Day/Memorial Day/random three day weekend? Your doctors office is closed.

:flower Tuesday. Finally you can go to the doctor. But what if they can't get you in? What if you don't have a car and no one is available to take you to the doctor? And isn't it only effective if taken within onehundred and twenty hours? When exactly is that up?

I don't have the energy to write anymore about this right now. Obviously I left out a lot of other emotions from getting raped and never went into reasons for why this person didn't go to the hospital or the police right away, but you get the idea. I didn't want to write a short novel about it. I tried to make a point, hopefully I did.

:bat battgyrll :bat
Sara

The only problem with your scenario is the implication that emergency contraception is not offered to alleged sexual assault victims. Not offering this goes against EM standard of care so at least in the USA EDs who don't offer are in the minority and may not exist at all (although since some hospitals fail to hold up other standards of care I suppose it is possible that they do exist) Additionally cost is not an issue or preclusion from seeking care since the ED charges for exam and medications are paid by the victim's assistance fund (which at least in this state does not require that you subsequently press charges---that may vary in other states). In your given scenario the person could have presented to the ED on Saturday and received emergency contraception.

:love,
Jen:bear

[shortstop]

Kensington beat me to that reply about being old enough. :sarcasm She said exactly what I was thinking reagarding that issue.
Unfortunately too many drugs are mis-used and it's the FDAs responsibility to determine which drugs can be disrubuted OTC safely.
I hope I get this out right...there are a lot of things on the market that the FDA allowed that are improperly used. Look at the :bowl...we improperly use food! There is a sense of personal responsibility that needs to be taken here, and America as a whole needs to get that. (about a lot of other things too) Of course I would hope that women go their gyno and see if they are even able to take the pill w/o side effects first, that would be the responsible thing to do. But at times there are extenuating circumstances like when minors are involved.
It also needs to be understood that it's not a contraceptive, but a last resort. I don't think that the FDA can take everything off of the market that is abused. That would include cough syrup, sleeping aids, and other such things. They even admitted in the article that :ribpink posted that some felt non-medical reasoning was used in the decision. Which to me, is out of their jurisdiction. There will always be a few people who do not do what they're supposed to do, but we can't be expected to live life according to the lowest common denominator.
I think I said that the right way...I'm not exactly sure. Sometimes it sounds a certain way in my head then comes out funny. :wacky Even though I'm a pretty articulate English major most of the time!!

[battgyrll]

Jen

I live in a community where EC is NOT available in the ER. There is nothing illegal about this at all in this state. Through my job we did a survey (too long to go into now, but trust that it was accurate) and seventy percent of the pahrmacies in this state do not have EC on hand, and EC is absolutely not available through our ER. THe next closest ER is ninety miles away. I don't think you can possibly understand this without living in a place like this.

:bat battgyrll :bat
Sara

[Marigold]

I'm thinking:
So What if it's used as regular birth control? That's not ideal either....but more ideal than an unwanted pregnancy...esp. for a teen or really, Anyone who's in a position of not being able to emotionally/financially/physically support a pregnancy.

It's better than abortion, which carries more risks and which some probably do use as a contraceptive option.

:hugonJen:hugoff, there was so much medical jargon and lingo in your post that I could barely wade through it to get to your point (please have mercy on those of us who are not medical proffessionals:grin)

but I think I got the jist of what you are trying to say to us.

I think Battgyrll brought up excellent points.

Even if medication is offered to women as a matter of norm if they are sexually assaulted...what about those who are overcome w/shame and trauma and can't admit to what happened to them...at least not right away?

Yes, :hugonKensington:hugoff, is absolutely Right:
in an :rainbowIdeal:rainbow world we'd never have to worry about such things but, as we all know...

this world is far from ideal:cry

Let's be realistic and admit what we already know - teens and even younger are going out and having sex all the time.

Sexaul assault is distressingly common.

This morning after pill, from what I gather, has been available in Europe for some time now (why are they always so ahead of the U.S in this kind of thing???? I think because they take a realistic view and don't try to impose morality on people, generally speaking)...

It's been available in Europe and it seems to work fine there.
So why not here too?

As for risk...everything we take, medication wise carries risks. Many people die each year from the effects of taking "approved" otc drugs and drugs prescibed by their doctors.


To sum up: I'd rather have women have :bulletEasy:bullet access to a morning after pill than court unwanted pregnancy.

-Marigold:sun

[elf]

Sadly, it's a reality in our society that younger and younger kids are having consensual sex. These kids are the least likely to use birth control and I also believe the least likely to use the morning after pill.
Also, I have a friend who used the morning after pill and it was no joy ride. It was rather miserable so I highly doubt there are many if any women who go around using it as a form of birth control.
I tend to agree that the whole issue is a smoke screen. There are a lot of drugs in this country that are approved by the FDA that can be quite dangerous, such as Vioxx.
Just my two cents :elf
susan

[Vicks]

Personally,

I feel that almsot all drugs should be OTC. Why? Over the Counter Drug abuse in many countries is extremely high. Many people don't read the labels and many people hence don't follow the instructions exactly as written. This is evident from the rise in young people in abusing cough medicine, which contains dextromethorphan, or DXM and when taken in excessive doses, it produces a high.

I don't beleive this particular drug, can be "abused" in the same way, but I do feel it can be used in a way where the "directions aren't followed" I mean, we have to admit, that many people out there, teens, kids and what not "can't read" If as many people in here are saying which is that "kids are kids" then how many of those kids will sit down and read word for word the directions ot the OTC? I don't beleive all of them will.

So am I glad it isn't OTC, yep you bet I am. And maybe it is different in Europe, I don't know, but instead of people having access to a drug, that needs to be have instructions read, I would rather society became more accepting, and more open where people in general do not have to fear getting the pill. If fear, wasn't around, then this pill needing to be OTC, wouldn't even be necessary. People aren't saying to make this pill OTC, because of its costs, they are saying "make it OTC so people don't have to talk to anyone"

Vicks

[battgyrll]

Another rant from me...

:madWhy is it that people feel that by putting EC OTC or making it available at all, that women everywhere will stop being responsible for their sexuality?:mad Studies have shown that women are no more likely to have sex or stop using other forms of contraception when they have access to EC. Women will still be concered with gettting STI's that are life threatening. Women are not stupid. We will not throw our brains out the window:reallymad! EC is not an ticket to free and irresponsible sex. It is a second chance.

:bat battgyrll :bat
Sara

[Vicks]

How come this debate has turned into a "moral debate" I don't see this issue as a "moral debate" I see it as a "medical debate"

The simple question I have for eveyrone is this:

If this drug is allowed to be sold OTC will it run the risk of being misused because people will not read the directions correctly, and/or not understand the writting on the bottle

If so, is it a safe drug to allow anyone to purchase and/or use without a pharmacist, and/or a doctor explaining how to use it?

At least if a doctor prescribes the OTC pill, they can explain to someone verbally what its side affects are and such.

Normally, I am a huge advocate for progress and I tend to side with the Europeans on a lot of issues. I consider myself liberal, but on this, I guess I jsut don't beleive all people will use it properly.

Vicks

[battgyrll]

Vicks,

The thing is, we cannot control whether or not people will read the instructions correctly or read the warnings. I don't see why this is any different than a person buying cough syrup or heartburn medicine and taking it without reading the instructions. People do it all the time. But more often then not, people read the directions. I just don't understand why so many people are all of a sudden concerned about people being responsible with OTC medicine. No one was concerned about it until the EC debate started.

This drug is not harmful. It is safe and meets thge FDA requirements for OTC availibility. I can spout those out if you want, but I don't have time right now. Also, the American Medical Association and the American College of Obstetricians and Gynecologists agree that it should be OTC.

:bat battgyrll :bat
Sara

[Vicks]

I suppose I would bann a lot of the OTC medications out there, because people don't take them properly. I hope that if the professionals feel it is ok, I wouldn't object to it being OTC. I don't know a lot about it, I will admit that, about the drug, I guess my concern always is people taking things and not understanding what they are taking and how to take them.

Guess, I would just hope the stigma of "why people don't want to talk to their doctors about why they need the pill, would be worked on. People are scared, if they weren't, would there be such an outcry for not having this pill be OTC?"

The whole moral debate, well that is Americas "puritanical" roots I suppose taking hold.
Vicks

[ribbon]

:hugon battygirl :hugoff I agree with you completely (some how I knew I would :muhaha). In the past decade and a half there have been so many formerly prescription medications now sold OTC. I remember all the hoopla when Monostat came out OTC.
Any medication, OTC or not can be misused.
If men were the ones having babies somehow I think the FDA would have already approved this :ohboy :muhaha.
Look who we have in the white house? The religious right wing has a strong influence over GWB and he's running for reelection (hopefully unsuccessfully :winky). As far as I'm concerned this is much more about anti choice than the medical safety of the medication.

[Marigold]

:starsBattgryll:stars,

I hope I didn't imply in any way that women would be "stupid" about their sexuality if the morning after pill becomes OTC.

I was just trying to address some concerns that will inevitably be brought up, esp. about young people, ocncerning this drug.

Of course, my own personal preference is for young people (gosh, using that term makes me feel so old) to wait to have sex...

but last time I checked, No One was consulting me about when to have sex:muhaha

-Marigold:sun

[Kensington]

If we're going to play the OTC drugs that may be abused card, let's get right to laxatives, which are abused by many people right here in the :bowl. Do I think they should be banned or available by prescription only in order to keep them out of the hands of people who might be eating disordered? Nope. The majority of people who use them do so for the right reasons - on a short term & only as rarely needed basis.

As others have mentioned, I also have a problem with the idea that if this drug is available OTC, women & girls (under legal age) will go hogwild using it as "birth control". I am NOT NOT NOT trying to open a discussion about abortion, but this does remind me of the idea that if abortion is legal, it means every sexually active woman in the US will schedule several abortions a year rather than buy birth control or abstain. Neither is true nor realistic. Most women can be trusted to make judicious reproductive choices for herself.

I don't believe this drug will be abused in the way its opponents portray it. Nor do I believe that women should abandon the responsibility of birth control for themselves. But the reality is that birth control is not one hundred percent. Rape & incest happen & not all people have instant access to medical help for several reasons: age, financial, insurance, & location. In my opinion dismissing a drug that allows females to take better control of their reproductivity is not something to dismiss.

Vicks, you brought up a "moral" vs. a "medical" debate & I do see your point. But unfortunately this is at the heart of most reproductive arguments, both political & personal, in that some people think abortion is a medical issue whereas others think it's a moral one & some people look at reproductive choices as moral while others see them as medical. Interesting world.

[PrettyKittie]

My concerns aren't with the fact that it is offered but with the fact that I don't think it should be offered over the counter.

Have it offered in places like Planned Parenthood and the like if people want it readily available but not over the counter. Why do people think that people who are too ashamed/shy/embarassed/whatever will not go to a doctors office but have absolutely no problems going to the local pharmacy?

[ribbon]

PrettyKittie said: Why do people think that people who are too ashamed/shy/embarassed/whatever will not go to a doctors office but have absolutely no problems going to the local pharmacy?

I think it's about privacy. Because you can go to a pharmacy anonymously. If you want to go to your doctor, obviously you're not anonymous. If you want to go to a different doctor then you have to lie about your name and other personal information. You probably also have to have an examination, which is highly stressful for a lot of women. Most doctors won't just give a prescription to someone who asks for it w/o an exam, particularly if they don't know the person.

[Vicks]

Kensington - thanks for the responce. I guess I never saw this Pill as something that has any sort of "moral issue" attachted to it. Put in our society, unfortuantely far to often "moral" issues enter areas that they have no business being in.

As far as Laxatives go, I would make them only available OTC, along with most medications out there, simply because OTC drug abuse is rampant, it won't happen, I am aware of this, but I suppose we all have wishes for things that are not entirely practical.

Vicks

Also - as an FYI I have a freind who is getting her Doctorate in Pharmacy and she said "you know we get samples all the time and for this pill all you need is one so I could give it out as a sample no problem - and you don't need a prescription for a sample"

[Shauna]

Vicks,

It would be kind of ridiculous to take most OTC drugs off of the shelves. Firstly, who says that people read the instructions on prescription medication vs. OTC medications? Secondly, if people want to abuse medication, they're going to. They'll double doctor, go to the streets, or buy it online to get it.

I don't think most women would start to use this medication as a contraceptive.

On the other hand, I don't see the need for it to be OTC. Perhaps for some of the reasons stated (such as Sara's reasons), but I don't see young girls going to the pharmacy getting it. In most cases, those girls wouldn't have access to a pharmacy outside of their town and probably wouldn't want to risk being seen.

It should be available in ER's though.

[ribbon]

Vicks, I agree with :hugon shauna :hugoff. ANY OTC drug can be abused or misused-- even certain vitamins can cause death when taken in large quantities. The vast majority of people take medication, both prescription and OTC the way they are intended.

[shortstop]

I don't understand why any drug should be taken off of OTC because people don't read the instructions correctly. I'm sorry to sound mean, but that is ridiculous reasoning. So the majority of Americans who would read their instructions are put out because of a small percent who don't use common sense? I don't think so. We already have enough things in our culture "dumbed-down"...not this too. For me, that kind of decision is too "Big Brother is watching" for me to swallow.
This pill is one that really should be OTC available, and the only reason it shouldn't be is if the FDA has decided that it is too unsafe for use yet. Of course, politics are going to play a role in this, so who knows what reasoning is going to rule over this decision.

[ribbon]

shortstop said: We already have enough things in our culture "dumbed-down"...not this too.

Ain't that the truth :sarcasm :muhaha :muhaha :winky.
Look at the ramifications from JJ's wardrobe malfunction :ohboy.

[Feak]

About drugs being taken off OTC cause they're misused. Paracetamol is very dangerous, quite a few people OD on it without realising it, or deliberatly :ugh But, hey, by the majority of people it's taken as directed, and helps people.

I work in a Chemist, even though it's the only one in the immediate area, we still get very few women in for the MAP. A couple a day at the most, most days none at all. Personally I think it's a good idea to have it avaliable, as it can be an arse to get to a Drs, and get the prescription, within the time limit.

When a woman comes in asking for it, she is taken to a consulting room to talk with the phamasist. He has to check if she's used it before, is on the pill, could possibly be pregnant already, and is over sixteen. If he isn't sure about the age, they need ID. It is quite controlled, and personally I think the cost of it is a big enough deterrant for women who may abuse it.

Yes, we all need to be responsible about our sexual health. Use condoms, to protect agaist STIs and pregnancy. But what if the condom slips off? Or breaks? What if you usually rely on the pill, but around that time get a stomach bug, rendering it unrelaible? Or, like others have pointed out, are raped.

The MAP is not something to be taken lightly, and I would not like to see it avaliable to anyone without a consultation. If you use it more than twice it can seriously interfere with your future fertility. Bombing your body with hormones isn't to be taken lightly. That's why the cost is high, a deterrant.

I would have to argue about having these things avaliable making people less cautious. Many of my friends (we're around eighteen) are on the Pill, and totally disregard condoms. As long as they can't get pregnant, they don't care. They think STIs just don't happen to them. Most of the time you don't know if you have an STI, as my friend found out when I kinda bullied her into getting checked out. As long as they're not pregnant, they don't care.

Yes, I am pro-choice, and I'm sure taking the MAP is a much better alternative to getting pregnant and either having an abortion or bringing an unwanted child into the world. BUT it is still needs to be controlled heavily. From speaking to my friends, I know many of them have taken it. And this is at eighteen, having only been sexually active a couple of years.

I'm happy with the way things are with the MAP though. It's avaliable, but screened and costly. To me, that's perfect. Avaliable, but still deterred. It is hefty hormones, and not something to be taken lightly.

On a similar note, GODDAMN PEOPLE NEED MORE SEX EDUCATION!!! In my area, you have a sixty percent chance of catching chlamidia alone after one unprotected sex. A couple of my friends (those that have been tested) have found out they have STIs. One of my friends is now pregnant at eighteen. The attitude of ignorance frankly pisses me off. Hell yeah, sleep with whoever you want, belive me I'm not prudish, but for god's sake protect yourself! :mad

Sorry to rant, my friend's pregnancy has kinda made this issue a little saw atm :ugh

[battgyrll]

GODDAMN PEOPLE NEED MORE SEX EDUCATION!!!

:reallymad um, yeah. That's my job at Planned Parenthood. I go out into the community and educate high school and sometimes middle school classes on STI's and contraception. It's not so much about people needing more sex ed, but realsex ed. I get so irritated at what the schools will "allow" me to say. I wasn't even allowed in our local high school until this year when three freshman got pregnant. ne of the girls was asked by the counsellor at school if she used protection and the girl had no idea what she meant. I've made huge progress here, but there are so many other places wherer they are still doing abstinence only and it still isn't working.

I could go on forever...:mad

:bat battgyrll :bat
Sara

[ribbon]

:hugon :bat :hugoff It's so great having you in the :bowl for your information and perspective. You have such an important job working with PP and educating people. Thanks for what you do :love.

[Feak]

ne of the girls was asked by the counsellor at school if she used protection and the girl had no idea what she meant.

:zoinks Geez, and I thought Essex was bad! :sarcasm Here we get sex ed, but it only overs the basics "sex is good when you're ready, use a condom, or you'll get pregnant or maybe an STI, here's a banana to pratice putting it on."

I'll second Ribbon (again :winky) on this, well done on the job you do!

[Shauna]

:hugonFeak:hugoff

Yeah, some people do need more sex education.

I just seen a case on Judge Judy the other day. This woman didn't really like this man, but they had five kids together. Judy asked why they had so many kids if they didn't like each other. The woman replied that the man wouldn't wear condoms. Umm......what? Apparently this woman never heard of the pill before. *shakes head*

:hugonSara:hugoff

Abstinence only? How on earth is that supposed to work in this day and age? Honestly. Isn't it time to be honest about sex? Kids have sex and if they aren't properly informed, they could end up either pregnant or with a STD before they can spell.

[Shauna]

There are some things that should be done regarding OTC medications though. For instance, why exactly are laxatives available in hundreds? Laxatives are only supposed to be meant for occasional usage, so therefore it would take most people about three years (if not longer) to go through a bottle. Same goes for products like Gravol. Plus, I know that kids in our area were abusing cold medications. I do think that products that can cause harm like laxatives, or can cause a high, should be available to those over the age of say eighteen and be placed over the counter. And they really should stop selling such mega bottles of them. They just aren't necessary and are often abused.

[Feak]

:hugon Shauna :hugoff

Yeah, the laxatives thing buggs me too. Thing is, some people rely on them long term, particularly old people, who have certain conditions, or can't get out and about much, or people with reacurring conditions like IBS. It's also cheeper to buy in bulk. So it's not all ED. It does say if you use them long term you should see your Dr, but Drs can tell you to use them long term, once they've worked out the problem. Cheeper to buy OTC than prescription a lot of the time too.

But, it does piss me off, I work in a chemist like I said, and the number of "typical" looking emaciated people with EDs who come in time and time again bulk buying laxatives :sad And that's not counting the majority of people who aren't "obvious" looking :ohboy Week after week, hundred packs. The worst thing is we can't do anything about it! :sad Can you say frustrating? :ugh

[IthinkIcan]

Maybe I'm weird about this, but I believe in having the same guidelines for all drugs, regardless of their relation to reproduction. Thus, if we are going to start moving potentially harmful drugs to the shelves, then I say "let's go for it." Let's become like Mexico and other countries where a certain amount of deregulation has put some of the power in the hands of the people. BTW, I'm NOT joking.

Medicine can be quite cost prohibitive both as an art/science an as a "drug."

Does the idea of this appeal to me? To a certain extent. How many times when I didn't have insurance did I have a condition such as bronchitis that I knew could be treated with x and y or a UTI that could be treated with z or even allergies that merely needed c, yet off to the doctor I had to go. I realize changes have been happening, and that certain meds have hit OTC now that ten years ago required a prescription. But, I feel more changes need to occur, especially as our current medical system stands.

Does the idea concern me? How couldn't it?! As a nurse the idea all but paralyzes my brain with fear. Regarding the med spoke of here, if the med prevents conception, then no school of thought should have problems with it. If it prevents implantation, then there are some, theoretically, who would. (Frankly, I've found conflicting information. Some argue vehemently that it prevents conception, and others just as nonchalantly say it preventions implantation of the fertilized egg. Personally, I've not cared enough to definitively find an answer *blush* say in a medical journal.) Interestingly, many of these would not speak up against similar methods of BC, which is what this is. IUD's, progesterone only prep's (Micronor, mini-pill's, and Depo-Provera) work by this method every month. The morality of this is not at question to me. Truly. At this point I feel it is a matter of splitting hairs and is a matter of conscious. But, I do worry about the medical safety of having such a product readily available when it is a HORMONE! I would worry of dangers with antibiotics. I'm angered by the ease of obtaining ************************--no, not just due to ED reasons, but these reasons are increased in EDs.

I worry that the counseling that takes place at the chemist where Claire lives would not take place here (and may not even be allowed). Signatures of a minor mean nothing. But, if we were to allow it to happen, I think we ought consider a practice similar to where Claire lives. Claire, is there a cut-off?

I do think it is WRONG if the only thing stopping this is concern that is a giving point or move toward abortion. Yes, it is a move toward the gray, but some things in life are. Not sure completely how I feel about it, but some of the reasons I've heard are bogus.

[ribbon]

As long as we're talking about medicine....
I think marijuana should be legal! In some states medical marijuana is legal for cancer and other seriously ill patients. It also comes in a pill, Marinol. I could have gotten it when I had chemo, but I didn't want or need it (buying a joint would have been way cheaper if I had been so inclined).
Any thoughts on legalizing marijuana (and/or other drugs)?

[IthinkIcan]

LEGALIZE IT . . . for medicinal use. This has been a public service announcement by ITIC.

Any questions?

[IthinkIcan]

I'm back. I swear, sometimes I feel like a chicken with my head cut off, although my life is far from busy. Just "complicated." Three day migraine I'm trying to ignore while retching. Picking up my daughter, cooking dinner, getting her ready and stretched out for dance, media stuff, recital stuff, all the while battling hormonal migraines and hot flashes, pelvic pain that doubles me over. I know it doesn't sound like much. Eh, anyway.

The marijuana thing. Yesh. An opinion.

Most who know me would consider me quite conservative--earlier today I cried about it (I wish to be a liberal but cannot be--amused? confused? well, if you aren't, I am). Just the same, having done research for debates I learned of the wonders of medicinal marijuana. I've never had a joint, but . . . well, I've never had opportunity either.

As a chronic painer I've been on some heavy duty meds and even had to detox off some (thankfully the University of Michigan assures me after scouring my records I was NOT a substance abuser, but, hey, even if I was) when I was there I was on the same detox as people coming off HEROIN!!! They didn't have people there for marijunana. Sure, I know the argument for it being a "gateway" drug, but the drugs one can end up on for pain often have a lot worse side effects and are a lot less natural than marijuana. This is to say, I would see being on OxyContin, MSContin, Duragesic, and others as a worse, but often necessary, evil than, perhaps, marijuana. I would just like to see it as another option. For some cancers and other pains it is THE BEST relief known, so I'm told, or so the research goes.

I suppose I feel much closer to this issue that the MAP issue, since I've been sterile for eight years, and we thought I was for fifteen prior to that. I definitely haven't had a typical female reproductive experience. Fertility has been my issue. That is why I have spoken to the drug issue as a whole.

[battgyrll]

I'm going to bring this back to the EC issue for a moment, and then I'm going to bow out if this becomes a marijuana debate, becuase that is an even more personal debate with me than EC, and somehow I always end up wrong (aka: huge trigger for me and am bowing out of this thread.)

:hugon ribbon and feak:hugoff

Thanks for appreciating me and my job!:touched

:hugon Shauna :hugoff
Yeah the abstinence only thing is stupid. Good thing Bush cut family planning funds but doubled the funding for schools that teach it, eh? Sometimes I'm jealous that you live in Canada. I saw a great political cartoon today in an anual report from one of our affiliates. It said at the botton "If we taught drivers ed the way we teach sex ed..." and showed a teacher tal,king to students with a drawing of a car on the chalkboard. The teacher was saying "Don't drive. Never get behind the whell of a car. In fact, just stay away from cars in general. It's the only way to avoid getting in an accident."

Here's the other thing...we don't trust someone to take EC responsibly, but we do trust them to be a responsible parent? Doesn't sound right to me! But I (unfortunately:sarcasm) don't make the rules...

:bat battgyrll :bat
Sara

[shortstop]

:hugonBattygirl:hugoff
we don't trust someone to take EC responsibly, but we do trust them to be a responsible parent? Doesn't sound right to me!
PERFECT!!! I don't think anyone could have said it better.

Okay...the marijuana thing; legalize it. Period. Medicinal or not, it should be legal. And this is coming from a :fishy that does NOT touch the stuff.

[Catherose]

I agree. People have the choice to use it or not. It's not a dangerous or addictive drug (unless, like anything else, it's abused). I think alcohol is probably more dangerous. From what I've heard it's more addictive, and I definitely think it's more likely to make people violent. Hemp is also good for a variety of purposes. I guess I'm generally against making something illegal unless it threatens safety. I don't see pot as particularly dangerous.

[Vicks]

I have a freind who is getting a doctorate in Pharmacy. Her and I have talked a lot about this, and I always tell her "you know I really am scared with the avalability of so many drugs being so readily available OTC" and she agrees. She has told me that "If doctors can make mistakes with drug interactions and such one wonders how many common mistakes the general public makes"

I wonder, what did we all do when most medications were "behind the counter?" Also, with the increase of an "over medicated society" more diseases are becoming "unaffected" by current anti-biotics. Unfortunately, I guess, the majority of people who take medication properly, may have to sacrifice a little bit for the people who "don't take medication properly" It won't happen, but honestly? Part of me wishes it would.

Also, perhaps if peopel spoke up more, when they know someone is taking medication wrong, then perhaps that amount of "abuse" and "inacurrate" taking of medication by people, would lessen.

Vicks

[IthinkIcan]

Therein lies some of my fears. Super infections already exist. MRSA. Now even VRSA!

It is already a problem with people who take more than four thousand milligrams of acetaminophen a day or who carelessly pair it up with alcohol or use it for prolonged periods while combining these.

Another problem is with people who have the mentality that if one is good two or three are better, discarding the directions; I think many of us here have been guilty of this when it has come to certain OTC products, despite knowing it is unsafe. There are those, however, who are just naive enough to think it must be okay since it is OTC, or that nothing will happen to THEM, or they just don't know.

Quite obviously those who study pharmacy or medicine (or even nursing) go to school for a number of years and take classes to educate them about medications. This statement is an oversimplification because with each step what is learned is more substantive.

Thus, I hope people understand what I meant by what I said. Basically speaking, from a safety/knowledge standpoint, I think we already have too many drugs available OTC, and I want to further qualify that my problem is not with the MAP per se but with the idea of giving certain PC/popular drugs the go ahead without further deregulation of the drug industry. This is to say I think it would be lacking in responsibility. However, that is not to say that I couldn't see benefits or couldn't argue both sides. I am, after all, human, and have been affected by exorbitant medical and prescription costs

Okay, so I've made no sense and have had to come back to this three times over several hours (actually went to watch Shrek Two during this time). :muhaha