Sunday, October 16, 2011

Get It Together XO Jane! Every Pharmacy In New York Is Out of Plan B For a Very Rood Reason! Every One!

This article is intended as satire, I think. Unfortunately, it's poorly executed satire and the topic is birth control. That's a dangerous combination in dire need of a remedy, or two.

Here's mine:

Plan B isn't pining for the fjords, it's no more

Pharmacies are out of Plan B because Plan B has been discontinued by its manufacturer quite some time ago. So forget about Plan B and familiarize yourselves with the available emergency contraceptive pill (ECP) brands.

Next Choice and Postinor

Next Choice and Postinor (outside the US) are the equivalent of Plan B -- 2 pill levonorgestrel (LNG), a progestin, dose brands available without a prescription and on Amazon. Take both pills at the same time (disregard label instructions), as soon as possible after the act of unprotected intercourse, up to 120 hrs/5 days. The sooner you use it, the more effective it is.

Plan B One-Step, i-Pill/Nextime, and Postinor 1/Postinor2 Unidosis

Plan B One-Step, i-Pill/Nextime, and Postinor 1/Postinor2 Unidosis are 1 pill LNG dose brands also available without a prescription and on Amazon (Plan B One-Step and i-Pill/Nextime). The instructions for use are the same as for the 2 pill dose brands -- take the pill as soon as possible, up to 120 hrs/5 days. The sooner you use it, the better.

ella

This a newer type of ECP, a 1 pill ulipristal acetate (UA), a second generation progesterone receptor modulator, dose brand available by prescription only. Have your physician write an advance prescription, fill it, and keep it handy to use when you inevitably find yourself in need of it on that long holiday weekend at 3AM. Same instructions for use; possibly more effective than the LNG brands when used after 72 hrs.

*Emergency* Contraception Pill

ECP postcoital birth control is only to be used in an emergency for the simple reason that it's not as effective as the other available methods when used on a regular basis.

The most effective regular birth control methods are the IUD and the implant.

Bottom line

Forget Plan B, remember Plan B One-Step, i-Pill / Nextime, Next Choice, Postinor, Postinor 1/Postinor2 Unidosis, and ella. Don't substitute ECP for regular birth control. And, last but not least, even in emergencies avoid attempts at satirical articles on birth control.

Labels: , , , , , ,

Monday, January 03, 2011

Emergency Contraceptive Pill News: The i-Pill Is Now Nextime

UPDATE: Looks like the i-Pill is back. So, the i-Pill and Nextime are the same drug, a one-pill 1.5 mg levonorgestrel emergency contraceptive pill, different brand names. Links for both the i-Pill and Nextime now go to their respective Amazon pages. See which one is available, buy it ahead of time, and keep it handy.

The one-pill emergency contraceptive brand i-Pill has a new name: Nextime

The Paras company acquired the i-Pill from Cipla and thought it a good idea to change the brand name. To one similar to another emergency contraceptive pill (ECP) brand already on the market. Brilliant, no? But I digress.

So, Nextime is a one-pill, 1.5 mg levonorgestrel (LNG, a progestin) emergency contraceptive pill. You take it as soon as possible after the act of unprotected intercourse, up to 5 days. The sooner you take Nextime, the more effective it is.

Both the i-Pill and Nextime are available on Amazon for $19.98.



Nextime should not be confused with Next Choice.

Next Choice is a two-pill, 0.75 mg LNG per pill, brand. (Next Choice is the generic for the now discontinued Plan B.) The regimen for Next Choice is the same--take *both pills* at the same time (disregard the label instructions) as soon as possible after unprotected intercourse, up to 5 days. The sooner you take Next Choice, the more effective it is.

Next Choice is also available on Amazon for $52.75.

You should also be able to find Next Choice in pharmacies (behind-the-counter for women and men 17 and older; with a prescription for those <17 yo). Best to call ahead and make sure your local pharmacy has it in stock and to inquire about the price.

To recap, the dedicated ECP brands are:

One-Pill, LNG



Two-pill, LNG



One-Pill, UA (ulipristal acetate)




Labels: , , , , ,

Monday, January 04, 2010

Plan B One-Step Cupon

You should always have emergency contraception like Plan B One-Step, Next Choice, or i-Pill handy if you're not planning a pregnancy but you might not always be too keen on the expense.

Good news on the financial front. Between a $10 off cupon for Plan B One-Step* from the manufacturer and the i-Pill for only $19.98 on Amazon the cost of a safe afterglow has become a bit more affordable. So, no more excuses, if you plan to have sex go forth and buy the emergency contraceptive pill first.

And since I mentioned emergency contraception, let me clarify a point I made in my last post on Plan B and Next Choice, and Plan B One-Step and i-Pill.

Plan B One-Step and the i-Pill are one-tablet (1.5 mg levonorgestrel) packs. You take the pill as soon as possible after the act of unprotected intercourse, up to 120 hrs (5 days). The sooner you take the pill, the better.

Plan B and Next Choice are two-tablet packs. The instructions tell you to take the first pill as soon as possible after unprotected intercourse up to 72 hours, and the second pill 12 hours later.

In my post I mentioned that you should disregard the instructions and take both pills at the same time (as soon as possible, up to 120 hrs). And why should you do that?

To make it easier on yourself. Research has indicated that both doses can be taken at the same time (one Plan B/Next Choice pill is 0.75 mg levonorgestrel, two are 1.5 mg; Plan B One-Step/i-Pill tablet is 1.5 mg) so, by taking both pills at once, you eliminate the risk of forgetting/something preventing you from taking the second dose 12 hrs later.


*Thank you, Stacey.

Labels: , , ,

Saturday, January 02, 2010

More on Plan B One-Step and i-Pill/ Nextime, Next Choice and Plan B

Princeton's Reproductive Health Technologies Project has a great chart of FDA approved emergency contraceptive pills (.pdf) currently available in the US.

Print it out, memorize it, and keep it handy! [May I suggest right next to your bed, you know, because there's nothing quite like whipping out a reference chart to enhance the mood.]



Two important things you should know:

1. Plan B, the two-pill packet, is being phased out (it's been discontinued). Don't be concerned if you cannot find it anymore. Use Next Choice, the two-pill generic instead or, even better, use Plan B One-Step or i-Pill / Nextime, the one-pill pack.

If you use Next Choice, disregard the package insert instructions to "take first tablet as soon as possible within 72 hours after unprotected intercourse and the second tablet 12 hours after the first dose". You should take both tablets as soon as possible after unprotected intercourse, up to 120 hours (5 days).

2. i-Pill / Nextime, the same as Plan B One-Step from Cipla / Paras, is available from (of all places!) Amazon for only $19.98.

Bottom line: If you are of reproductive age, sexually active and not planning a pregnancy, the emergency contraceptive pill should always be within your reach. Don't wait for an emergency to happen and then launch into a mad dash to find a place that stocks it. Be prepared and have the emergency contraceptive pill handy.

Labels: , , , ,

Monday, August 24, 2009

i-Pill / Nextime Emergency Contraceptive Pill

SECOND UPDATE Nov. 2011: Back to i-Pill on Amazon, with Nextime now out-of-stock. The i-Pill and Nextime links now go to their respective Amazon pages. Just see which one is available and buy it, they're the same ECP.

UPDATE: The i-Pill's brand name has been changed to Nextime. I've changed the post to reflect that.

Leave it to Amazon to alert us to the availability of the i-Pill / Nextime emergency contraceptive pill. What is the i-Pill / Nextime?

You already know what Plan B and Plan B One-Step are. The i-Pill / Nextime is the same as Plan B One-Step and, since we're on the subject, the same as Levonelle One Step/Levonelle 1500 (different manufacturers, of course).





Plan B -- 2 pills (0.75 mg levonorgestrel/pill); take both pills at the same time as soon as possible after unprotected intercourse, up to 120 hours (5 days).

i-Pill/Nextime/Plan B One-Step -- 1 pill (1.5 mg levonorgestrel); take the pill as soon as possible after unprotected intercourse, up to 120 hours (5 days).

  • The i-Pill / Nextime, like Plan B One-Step, is an emergency contraceptive pill. You take it to prevent pregnancy *after* an act of unprotected sexual intercourse. The sooner you take it the more effective it is (up to 89% reduction in pregnancy risk).

  • The i-Pill / Nextime doesn't work if you're already pregnant. It will not terminate a pregnancy.

  • Because the i-Pill / Nextime contains only a progestin (levonorgestrel) you can take it even if you can't use regular birth control pills.

  • The most common side effects are nausea, vomiting, breast tenderness--should resolve in a day or two--and menstrual changes. Most likely you'll have a normal period within the next month, but sometimes the next period can come as much as a week earlier or a week later than usual.

  • Last, but not least, don't use the i-Pill / Nextime as regular birth control. Once you've resolved the emergency, select a birth control method that meets your needs and use it correctly and consistently.

Bottom line: If you are a sexually active woman or man of reproductive age and you're not planning a pregnancy you need to have the emergency contraceptive pill handy.

So go check out the i-Pill Emergency Contraceptive Pill / Nextime Emergency Contraceptive Pill at Amazon where it's on sale for a [surprisingly] reasonable $19.98.




N.B. Other than the Amazon link, I have no financial interest in/ties with any of the ECP manufacturers.

Labels: , , , , ,

Wednesday, August 05, 2009

Plan B One-Step and Next Choice



The FDA has approved Plan B® One-Step, a new one-pill formulation of the emergency contraceptive Plan B.

Plan B® One-Step is one progestin-only pill (1.5 mg levonorgestrel) you take as soon as possible after unprotected intercourse (most effective within the first 24 hours). The i-Pill is another one progestin-pill emergency contraceptive pill brand, from a different manufacturer.

And speaking of new FDA approvals, the FDA also approved Next Choice™, a generic version of the original two-pill Plan B® formulation.

All clear? Let's review:

Plan B -- 2 pills (0.75 mg levonorgestrel/pill); take both pills at the same time as soon as possible after unprotected intercourse, up to 120 hours. **Plan B had been discontinued.**

Next Choice™ [Plan B generic version] -- 2 pills (0.75 mg levonorgestrel/pill); take both pills at the same time as soon as possible after unprotected intercourse, up to 120 hours.

Plan B® One-Step/i-Pill -- 1 pill (1.5 mg levonorgestrel); take the pill as soon as possible after unprotected intercourse, up to 120 hours.

Oh, and in case you forgot:


Although ACOG is encouraged by recent FDA actions, it reiterates its long-held position that there is no valid scientific or medical reason to impose an age restriction on the availability of EC because it is safe and effective for adolescents and women of all ages. ACOG again urges the FDA to withdraw the age restriction altogether and eliminate the behind-the-counter status for EC.


Check out the i-Pill Emergency Contraceptive Pill at Amazon where it's on sale for only $19.98.


ETA: I've added the information about the i-Pill to the original post.

Labels: , , , ,

Saturday, May 02, 2009

Missouri Politicians Abolish Professional Duties, Standards for Pharmacies

Missouri politicians just passed a law that strikes a serious blow to Communism on American soil.

The Missouri House on Tuesday voted 115-43 to approve HB 226, an amendment that [s]pecifies that no pharmacy can be required to perform, assist, recommend, refer to, or participate in any act or service resulting in an abortion and it will be immune from liability for refusing to do so.

By definition, when it comes to women of reproductive age, refusing to provide professional services to patients you deem undesirable is an inalienable right. As such, there's nothing special about politicians enacting laws to shield medical professionals from liability. These politicians are just doing [insert deity of choice]'s work. (Hear that malpractice lawyers!)

What is remarkable about Missouri's HB 226 is that it represents a quantum leap forward from the noble pursuit of playing games with your untouchable patients' trust, dignity, and health without any professional or legal liability.

This law HB 226 allows pharmacies and pharmacists to take advantage of all the benefits of having a monopoly on the sale of drugs without any requirements to abide by those pesky professional duties and standards that are usually a condition of being granted a State monopoly.

Like so:

No licensed pharmacy in this state shall be required to perform, assist, recommend, refer to, or participate in any act or service...

No duty to dispense drugs, talk to or advise patients, refer them to another pharmacist, or refrain from stealing taking a patient's prescription and refusing to return it to her.

...in connection with any drug or device that is an abortifacient, including but not limited to the RU486 drug and emergency contraception such as the Plan B drug...

No requirement to adhere to the professional standard of using science when dispensing drugs. (The medical definition of abortifacient is out, the personal definition is in.)

No duty to dispense drugs to *pregnant* patients, since most prescription medications are Category C. (Good luck with that asthma attack if you're a pregnant woman in Missouri!)

...not limited to the RU486 drug...

No requirement to stock or dispense a drug, RU-486, that cannot be legally stocked by pharmacies or dispensed by pharmacists to begin with.

No duty to provide pain meds or antibiotics to a patient who's been administered misoprostol and RU-486 by her physician, or, for that matter, to a patient who has an IUD, is already using birth control pills, or to men who are wearing tight underwear. (Hey, when you legislate science out of medicine, defining man panties as a device that is an abortifacient is perfectly valid.)

You tell me, what is more anti-communist than having the State grant a monopoly to an enterprise, remove duty and standard requirements, and then shield the entity from liability?

Here is the full text oh HB 226; read it and weep:

338.575. 1. No licensed pharmacy in this state shall be required to perform, assist, recommend, refer to, or participate in any act or service in connection with any drug or device that is an abortifacient, including but not limited to the RU486 drug and emergency contraception such as the Plan B drug.

2. No civil or criminal cause of action shall accrue against a pharmacy due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.

3. No board, commission, or other agency or instrumentality of this state shall deny, revoke, suspend, or otherwise discipline the license of a pharmacy, nor shall it impose any other condition of operation due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.

4. No pharmacy shall be denied or discriminated against in eligibility for or the receipt of any public benefit, assistance, or privilege of any kind due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.


One last thing. I have a question for Rep. Ed Emery, Rep. Cynthia Davis, and all the other Missouri politicians who passed HB 226. Since you've removed the professional duty and standard requirements for the sale of drugs, can I haz street stand for the glorious, Capitalist selling of Plan B in your state?


(via)

Labels: , , , , , ,

Monday, March 23, 2009

Judge Requires FDA to Reconsider Restricted OTC Plan B Sales

I told you so, there's no medical reason to restrict OTC Plan B sales to those 18 and older:

NEW YORK – The Food and Drug Administration let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication.

In a thorough denunciation of the Bush administration, U.S. District Judge Edward Korman blasted the FDA's handling of the issue, saying it had "repeatedly and unreasonably" delayed issuing a decision on the medication.

The morning-after pill is a source of tension for social conservatives who held great sway in the Bush administration and who believe the pill is tantamount to abortion.

The ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions only took action to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.

"These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making," Korman said. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use."

The drug is marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B. Korman ordered the FDA to permit Barr Pharmaceuticals to make Plan B available to 17-year-olds without a prescription under the same conditions as Plan B is now available to women over the age of 18. He said his order must be complied with within 30 days.

The FDA said it is reviewing the judge's decision. Women's groups said it's unlikely that the Obama administration would appeal.

...

In February 2001, the Association of Reproductive Health Professionals and 65 other organizations petitioned the FDA to make Plan B available over the counter to all, regardless of age. The FDA did not respond for five years, announcing in 2006 that the petition was denied.

As part of his order, Korman vacated the petition's denial and required the FDA to reconsider its decisions regarding the Plan B switch to over-the-counter use.


There are three things in the linked AP article I find puzzling.

First, the continued use of the zombie mistake -- [Plan B] contains a high dose of of birth control drugs. There's only one drug in Plan B, a progesting. While progestin is one of the drugs found in combination birth control pills, Plan B is not a combination drug. This distinction is important for two reasons. One, there are dedicated combination ECP brands and regimens. Conflating Plan B, a progestin-only brand, with combination brands is inaccurate and can be confusing for patients. Two, a combination pill or regimen has a different side effects profile than a progestin-only one like Plan B. For example, nausea and vomiting are more common after taking a combination ECP brand.

And speaking of MSM articles on Plan B and mistakes, here's one more correction. From this Washington Post article (via):

A federal court today ordered the Food and Drug Administration to reconsider the agency's controversial decision limiting non-prescription access to the morning-after pill Plan B to women age 18 and older.


Can you spot the sloppy reporting misinformation? OTC access to Plan B isn't limited to women. *Men* and women can purchase Plan B, as long as they're 18 and older.

Second, the insistence on passing off the Family Research Council's propaganda skilz as relevant to a discussion of scientific/medical matters:

The conservative Family Research Council said the judge's decision bowed to ideological pressure from the left.

"Judge Korman has accepted lock, stock, and barrel all of the claims of a political ideology promoting sexual license for teens," said Chris Gacek, a regulation expert with the group.

"There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent," Gacek added in a statement.


It's misleading to present silly accusations (incompetent legal decision based on ideology rather than medical evidence), scientific ignorance (promoting sexual license for teens), and bizarre claims about the FDA's regulatory process (Plan B may be given to women under coercion) as informed commentary.

Last, but not least, what exactly is the thinking behind the Obama administration defending the arbitrary restriction on OTC sales of Plan B: "It was enacted during the previous administration, now we're in the White House so, what the heck, let's just go with the flow?" Clearly, as a federal agency, the FDA has to be represented by an administration lawyer. But why does the government have to persist in defending the indefensible?

Bottom line: The decision to require the FDA to allow 17-year-olds to obtain Plan B OTC is a step in the right direction, but we still have to wait and see if the current administration will allow science to govern reproductive health matters.

Labels: , ,

Saturday, December 13, 2008

Plan B TV Ad


Photo via

Just saw, for the first time ever, an ad for Plan B on We tv (shown during a program on female criminals, heh!).

It's not yet online anywhere and I'd like to view it at least one more time before critiquing it, but, overall, good for We for airing an ad about emergency contraception.

Labels: , , ,

Monday, May 05, 2008

Missouri Senators: RU-486 On Par With Morphine and Opium


Photo by pasotraspaso


RU-486 is the opium of the [female] people, according to Missouri politicians.

Missouri Senators in a vote of 34-0 approve a bill, designed to track the sale of controlled substances and cold medicines, that puts RU-486 in the same category as morphine, opium and pain pills.

Less than a half hour after the bill's passage, Sen. Norma Champion, who is anti-abortion rights and the bill's handler [is that like a bear handler?], asks the Senate to reconsider the bill minus any mention of mifepristone because:

Turns out [RU-486] wasn't supposed to be in the bill.

It was left in because of a clerical error. The House had originally tacked it on as amendment.

...

"There was a problem with the computer version, for one reason or another," Champion told her colleagues.


Why these Missouri politicians believe that we've all just recently fallen off a turnip truck is unclear.

First, just the fact that, at any point in crafting this bill, RU-486 was even considered for inclusion in a bill designed to track drug sales is indefensible.

Medically, there's no justification for singling out RU-486 for this degree of government intrusion. RU-486 is a safe and effective drug with no addictive potential.

Politically, the lackeys at the FDA have already taken care of regulating RU-486 based on ideology, not science.

Briefly, the FDA restricts the distribution of RU-486 because the Agency determined that post-marketing distribution restrictions on the product were necessary to ensure its safe use.

Yeah, right! To use just one example, associated deaths: Viagra 5/100,000 prescriptions; RU-486 1/100,000 prescriptions. And, unlike Viagra, RU-486 has not been shown to have contributed to any deaths.

The FDA has determined that post-marketing distribution restrictions on Viagra were not necessary to ensure its safe use.

Second, a bill with an inappropriate provision, as per the bill's handler, sails thorough and gets voted on and "oops, it was a clerical error" is deemed an acceptable excuse. Are there no controls in place to insure a bill's accuracy? What assurance do the people of Missouri have that previous bills don't contain a provision to legalize slavery, or make Satanism the official state religion? Or are we to believe that this was the one and only clerical error in the history of the Missouri Senate?

Third, and most worrisome for the people of Missouri, 34 Senators vote on a bill without bothering to read it. I don't understand how that's possible. If you're a constituent maybe you could ask each and everyone of these Senators for an explanation.

But wait, there's more!

In 'Morning after' pill restriction said to be error, an article on the debacle, Chad Livengood, reporter for the Springfield News-Leader, writes that:

RU-486, or mifepristone, is an emergency contraceptive ingested orally to prevent or delay ovulation.


Thunk, thunk goes my head as it hits the desk repeatedly.

That 34 elected officials voted to pass a bill that they hadn't even bothered to read is, perhaps, not scandalous. They are, after all, just politicians. That a reporter can't be bothered to get his facts straight is.

If your article is about the 'Morning after' pill you need to at least mention Plan B somewhere in the article. You need to also make it clear that "morning after" pill is the lay term for the post-coital emergency contraceptive Plan B. The very same Plan B that's a progestin (levonorgestrel), an emergency contraceptive ingested to prevent or delay ovulation, and, most relevant here, an OTC drug (with some politically based age restrictions).

Of course, Chad Livengood's article isn't about Plan B but rather about RU-486. The very same RU-486 that's an anti-progestin (mifepristone), an abortifacient (or an emergency contraceptive, depending on dosage and regimen) ingested to cause shedding of the uterine lining (or prevention of ovulation and endometrial shedding when used as birth control), and a drug with a federally mandated distribution restriction.

So, to recap. First, 34 Missouri Senators vote on a bill they haven't bothered to read. Then, the Senators get a do-over [you know, how you do when you're responsible for a major screw up at your job]. Finally, a Missouri newspaper can't be bothered to get the facts straight and avoid misinforming its readers.

Well done Missouri!

Labels: , ,

Saturday, May 03, 2008

By the Grace of God, Court Affirms Belief-Based Plan B Sales

Religion trumps science
Photo by babasteve


When it comes to dispensing Plan B, a safe and effective drug with no major side effects, it's not only the pharmacist's religious beliefs that take precedence over the patient's health, her autonomy and her relationship with her physician.

The pharmacist's religious sado-masochistic tendencies also play a deciding role. For you see, as long as the pharmacist keeps his/her S&M tendencies in check and only inflicts reparable harm on the patient, it's acceptable for the pharmacist to commit malpractice and refuse to sell a legal drug.

Bottom line: A court just decided that, when it comes to Plan B, suffering irreparable harm is the standard for access to an OTC drug. There's no way to go but down from here.

Labels: , ,

Wednesday, March 05, 2008

The Association of American Physicians and Surgeons Knows Plan B Propaganda


Photo by u2canreed


Great news:

WASHINGTON (Reuters) - A federal judge on Tuesday dismissed a lawsuit seeking to halt sales of the only "morning-after" contraceptive pill available in the United States without a prescription.

The suit was filed against U.S. health regulators over their decision to allow non-prescription sales of Barr Pharmaceuticals Inc's Plan B pill.

The U.S. Food and Drug Administration and Barr were sued by the Association of American Physicians and Surgeons and other groups seeking to overturn the FDA decision.


Wait, what? A legitimate medical organization suing to restrict Plan B availability? Something doesn't sound right here.

Having never even heard of the Association of American Physicians and Surgeons (do I lead an insular life, or what?), I looked it up ( more here, and here). And figured out what the problem was (emphasis mine):

AAPS emphasizes that childbirth confers undeniable health benefits on the mother, and interruption of a pregnancy is indisputably harmful compared to childbirth. The FDA should not render any decision concerning increased availability of a drug to interfere with pregnancy without hearing from all sides of the medical community about the harm of preventing childbirth.


Turns out AAPS isn't so much a medical organization as it is just another crank propaganda outfit. And not a very good one at that [undeniable health benefits, indisputably harmful, the harm of preventing childbirth, seriously?].

Still, as lame as AAPS's propaganda might be, I can't help but notice that it's still far more effective than the [nonexistent] counter propaganda effort from those on the side of science and reality.

Labels: ,

Friday, February 22, 2008

Belief-Based Pharmacology

Kevin Stormans
Photo by sonofgroucho



"The Constitution tells me that I should have the ability to practice what I believe is right."

Had I known that the Constitution and personal belief guide the practice of pharmacology I wouldn't have bothered with reading all those pharmacology books.

Maybe I'll move to Washington state and, in cooperation with Stormans pharmacy, start a belief-based medical practice.

Labels: , , ,

Saturday, October 06, 2007

Plan B, Pharmacists And You

When it comes to information about Plan B it seems news stories go out of their way to confuse you.

Reuters reports on the FDA's statement that the agency is considering creating a new category of drugs that would be available without prescription at drugstores, but only after consultation with a pharmacist; the so-called "behind-the-counter" (BTC) drug category.

A consultation with the pharmacist means the pharmacist screens you and decides if it's appropriate for you to use the drug, and he/she consents and counsels you about the drug.

The article points out that [o]nly a few behind-the-counter drugs, such as Barr Pharmaceuticals Inc's Plan B birth control drug, are now sold in the United States.

Using Plan B as an example of a BTC drug is borderline misleading and confusing.

Misleading

If you're 18 and older, Plan B is OTC. A consultation with a pharmacist is not required to obtain Plan B. All you need to do is show proof of age to the counter person. The pharmacist has no say in your decision to use Plan B. The pharmacy personnel's only role is to card you in order to enforce the [capricious] age restriction decreed by the FDA.

If you are 17 and younger, Plan B is Rx only (see exception below). You also don't need to consult with a pharmacist to get the drug. All you have to do is present a script. Again, the pharmacist has no say in your decision to use Plan B. His/Her role is to fill a valid Rx.

Confusing

Under certain circumstances Plan B is actually BTC. If you are 17 and younger and live in California, Washington, Alaska, Hawaii, New Mexico, Maine, New Hampshire, Massachusetts, Vermont, or Montana, depending on the pharmacy, Plan B is BTC. You don't need a Rx to obtain Plan B but you do need to consult with a pharmacist. The pharmacist is the one who decides if it's appropriate for you to use the drug.

People who need to use Plan B, a very safe and effective drug, already have to navigate a formidable obstacle course. Between the FDA, where ideology guides drug regulation, unscrupulous pharmacists who steal prescriptions and refuse to sell the drug, incompetent politicians intent on legislating fact and reason out of existence, and the relentless and vicious propaganda of assorted religionists and perfect strangers, misinformation and confusion about Plan B reign supreme.

The least news organizations can do, when it comes to stories about Plan B, is make sure the information they provide is accurate and, as important, that it's presented in a clear manner.

Labels: , ,

Saturday, September 29, 2007

Plan B And The Selective Right To Bodily Integrity

When you voluntarily ask a government clinic to give you, and the clinic does give you, a pill to prevent pregnancy, you get to sue the government (.pdf) for violating your constitutionally protected right to bodily integrity, family privacy and religious freedom.

Which makes me wonder. When the government forces you to carry a pregnancy to term, what do you get to sue the government for? An extra, super duper, violation of your right to bodily integrity, family privacy and religious freedom?

And while we wait for our irony meters to return from the repair shop, let's use this case as a teaching moment.

You have a 16 yo sexually active female, not currently using any birth control (and, we can infer, no prior use) requesting the emergency contraception pill (ECP). You decide to go with a combination regimen, and give her 8 tabs of Nordette, to be taken in two separate doses of 4 pills (0.6 mg of levonorgestrel and 120 µg of ethinyl estradiol), 12 hrs apart. When the patient asks if the pills will make her sick you tell her to drink ginger ale to minimize side effects.

What could you have done differently, and why?

Well, two things.

1) Use Plan B

First, you could've given her Plan B, a progestin-only regimen, instead of Nordette, a combination estrogen/progestin regimen. By using Plan B you maximize compliance and minimize side effects. Plan B consists of only two pills; both can be taken at the same time (1.5 mg levonorgestrel). Plan B also doesn't contain estrogen and is less likely to cause side effects.

As you know, ECPs have no serious or long term side effects. [The only contraindication is known pregnancy because ECPs won't have any effect.] However, some women do experience minor side effects when using ECPs, mainly nausea and vomiting. [Other problems: headache, dizziness, lower abdominal pain, breast tenderness, vaginal bleeding.]

Studies have shown that a progestin-only ECP like Plan B is less likely to cause nausea and vomiting:

Plan B (progestin-only ECP)

  • 23% (~one in four) of users experience nausea

  • 6% (~one in 17) of users throw up

Nordette (combination ECP)

  • ~51% of users experience nausea

  • 23% (~one in four) of users throw up

2) Use meclizine

Second, in order to minimize side effects, in addition to ginger ale, you could've advised the patient to use an OTC anti-nausea drug:

To prevent nausea and vomiting, you can take the non-prescription anti-nausea medicine meclizine (also sold under the brand names Dramamine II or Bonine). Research shows that taking two 25 mg tablets 1 hour before using combined emergency contraceptive pills reduces the risk of nausea by 27% and vomiting by 64%, but this drug doubles your chances of feeling drowsy (to about 30%).


[Keep in mind that if you vomit within 1 hr of taking an ECP dose it's best to repeat the dose.]

Labels: , ,

Sunday, July 15, 2007

The Washington Post Botches Article On Plan B

The Plan B article by Rob Stein in the Washington Post is a joke.

Here are the top 5 reasons why:

1. Use of incorrect and misleading terminology.

Plan B is not so much the morning-after pill as it is the emergency contraception pill.

When your article opens with The popularity of the morning-after pill Plan B has surged... without an indication that morning-after is an incorrect term, you are giving your readers misleading information. [And, no, having controversial emergency contraceptive (controversial?) in the same phrase doesn't count. "Morning-after" has to do with dosage timing, "emergency contraceptive" refers to the name of the contraceptive class.]

You take Plan B after an act of unprotected intercourse in order to prevent an unintended pregnancy. The sooner you take it--ideally, immediately after sex or within the first 12 hours--the better it works. But, and this is very important, you can use Plan B up to 5 days (120 hours) and still reduce your pregnancy risk. Referring to Plan B as the "the morning-after" pill without a qualifier is detrimental because it leads to incorrect usage.

You don't have to wait until the morning after to use Plan B. You can take it right away (preferably) or up to 5 days after unprotected sex.

2. Passing off a consistent position as evidence of a surge in controversy.

Rob Stein asserts that approval of Plan B OTC sales and the resulting increased use has lead to a surge in controversy about making Plan B available without a prescription. One piece of evidence he offers to support his assertion is that conservative groups that fought the change say they are disturbed by the surging use...."We think [the surging use] is putting women's health at risk."

Use of a drug (prescription-only or OTC) known to have detrimental side effects can put users' health at risk. Plan B is a drug. Like any drug Plan B has side effects. That Plan B has no serious or long term side effects is a medical fact.

The surging use of Plan B, a drug without serious or long term side effects, is not putting women's health at risk.

Now, conservative groups like the Family Research Council have never based their discussions about Plan B on medical evidence. They have been consistent in their use of propaganda--Plan B puts women's health at risk--and their ignorance, real or feigned, of science. Conservative groups used propaganda to feed to gullible reporters elicit controversy about Plan B when the drug was available by prescription only. And now that Plan B is available OTC, they continue to use the exact same propaganda.

How is maintaining a consistent position--continued ignorance of science and use of propaganda--on the part of conservative groups evidence of an increased surge in controversy?

3. Incorrect information about Plan B's ingredients.

It's possible Plan B consists of higher doses of the hormones found in standard birth control pills in mirror-Spock's universe. But if we're limiting our discussion to Plan B's ingredients here on planet Earth, we need to be accurate.

Plan B consists of a higher dose of one of the hormones [levonorgestrel, a progestin] found in standard combination birth control pills. Alternatively, Plan B consists of a higher dose of the hormone found in standard progestin-only birth control pills.

And just in case Mr. Stein was confusing Plan B with Preven, an emergency contraceptive pill which actually consists of higher doses of the hormones found in standard birth control pills: Preven is no longer available in the US, and this is an article about Plan B, not Preven.

4. Misleading readers about questions asked and answered.

Mr. Stein tells us that Conservative members of Congress and advocacy groups questioned the drug's safety and argued that easier availability could encourage sexual activity and make it easier for men to have sex with underage girls. They also maintain the pill can cause the equivalent of an abortion.

Approving a drug for OTC sale when there are questions about its safety, public health impact, and mechanism of action. Now that's one juicy controversy!

Except science has already asked and answered these questions.

Plan B has no serious or long term side effects. [See #2.]

The impact of OTC use is well documented in the medical literature. Progestin-only emergency contraceptive pills like Plan B have been in use without a prescription for years (in Europe, of course). The evidence shows that easier availability does not increase risk taking, either for adults or adolescents (projection fantasies about Plan B and men having sex with underage girls notwithstanding).

Finally, Plan B does not cause abortion.

Just because Conservative members of Congress and advocacy groups pretend-question the evidence about Plan B in an attempt to mislead the public does not mean you report their questions and leave it at that. Since you have an obligation to be factual, you have to note their deceit and give your readers the correct information about Plan B's safety, impact, and mechanism of action.

5. Misrepresenting the FDA's findings on Plan B.

The FDA did not say there was too little safety data to approve the drug for teenagers younger than 18.

What the FDA actually said is that for women 17 and older the existing Rx dispensing requirements for Plan B are not necessary to protect the public health and that an Rx-only to non-prescription switch for those consumers is authorized under 21 U.S.C. 353(b)(3) and 21 CFR 310.200. (emphasis mine)

Note to Mr. Stein: 17 and 18 are not one and the same. But then, what's a year here and there between political ideologues. In any case, when you report on what the FDA said, even if the agency's statement is just propaganda, you still need to insure you are reporting the propaganda accurately.

And speaking of the FDA, why exactly is what the agency said about Plan B OTC sales propaganda?

Since, clearly, just reading the Washington Post won't provide you with this information, allow me. Because the age restriction is not based on any scientific evidence that Plan B is not safe for women under 17. It is a purely political decision.

From the GAO report, Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual (.pdf):

There are no age-related marketing restrictions for safety reasons for any of the prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. All FDA-approved OTC contraceptives are available to anyone, and all FDA-approved prescription contraceptives are available to anyone with a prescription. For hormonal contraceptives, FDA assumes that suppression of ovulation would be the same for any female after menarche,13 regardless of age. FDA did not identify any issues that would require age-related restrictions in its review of the original application for prescription Plan B, and prescription Plan B is available to women of any age.


And from the FDA's Director of the Center for Drug Evaluation and Research, the person in charge of making public health decisions about Plan B, Dr. Steven "I'm Not Familiar With Plan B's Side Effects" Galson:

[Dr. Galson] said that the age restriction (which was originally set at 16) was changed to 18 to make it less confusing for pharmacists to enforce.


Mustn't.Confuse.The Pharmacists.

So, there you have it. A Washington Post article on Plan B which manages to misreport both basic medical facts about Plan B, as well as the less-than-subtle political propaganda directed at Plan B by some Conservatives and the FDA. Well done!



(via Our Bodies Our Blog)

Labels: , , ,

Tuesday, July 10, 2007

Bush Administration Censored Talk On Birth Control And Sex Ed

So says Dr. Richard Carmona, the former U.S. surgeon general appointed by President George W. Bush (emphasis mine):

WASHINGTON (Reuters) - The first U.S. surgeon general appointed by President George W. Bush accused his administration on Tuesday of political interference and muzzling him on key issues like embryonic stem cell research.

"Anything that doesn't fit into the political appointees' ideological, theological or political agenda is ignored, marginalized or simply buried," Dr. Richard Carmona, who served as the nation's top doctor from 2002 until 2006, told a House of Representatives panel.

"The problem with this approach is that in public health, as in a democracy, there is nothing worse than ignoring science, or marginalizing the voice of science for reasons driven by changing political winds. The job of surgeon general is to be the doctor of the nation, not the doctor of a political party," Carmona added.

Carmona said Bush administration political appointees censored his speeches and kept him from talking out publicly about certain issues. He mentioned political interference preventing him from discussing the science on embryonic stem cell research, contraceptives and his misgivings about the administration's embrace of "abstinence-only" sex education.

Carmona's comments came two days before a Senate committee is due to hold a hearing on Bush's nomination of Dr. James Holsinger, who faces Democratic criticism, as his successor. The administration allowed Carmona to finish his term as surgeon general last year without a replacement in place.


I can't say I'm utterly surprised by the confirmation that this administration is censoring accurate reproductive health information. What I don't get is this administration's blinding ideological fervor. I mean, all the players involved are seasoned political operatives. They must be aware that actively working to substitute propaganda for science fundamentally, and irreparably, damages the process. They must also be aware that they don't get to rule for life or install their successors.

Once it has become acceptable to make health policy and medical decisions based on propaganda, any subsequent administration can, and will, propagandize science and medicine according to the dogma of its preferred Sky Fairy or "Power to the People" ideology.

This administration got away with a trailblazer--using the FDA to decide a drug's (Plan B) availability based strictly on party ideology. It set the precedent for a future administration to behave equally as irresponsible.

When a future administration institutes a one-child policy, or executes officials who don't tow the party line, or makes stoning part of the treatment protocol for rape patients, we mustn't forget to thank the Bush administration for its visionary conduct.

Labels: ,

Friday, April 13, 2007

Population Effect of Increased Access to Emergency Contraceptive Pills

Ann alerts me to the fact that there are some questions about one of Dr. Trussell's studies, Population Effect of Increased Access to Emergency Contraceptive Pills.

As I mentioned to Ann, I don't see anything particularly noteworthy about it, but I don't have time now to get up to speed on who's claiming what about the study, so here are some excerpts to assist you with your own research:

Of the 3.1 million annual unintended pregnancies in the United States, most result from situations in which pregnancy risk is immediately evident: a condom breaks, birth control pills are taken inconsistently, or incorrectly, or no contraception is used at all.1 Increasing women's ability to obtain and use emergency contraceptive pills promptly after such events should improve their chances of averting pregnancy. A modeling exercise published in 1992 suggested that widespread use of emergency contraceptive pills had the potential to cut the number of induced abortions in the United States by at least half.2

During the past several years, this potential has been assessed in numerous studies that evaluated various strategies designed to enhance women's access to emergency contraceptive pills. Here we review the findings of these studies, focusing particularly on the strategies' effect on emergency contraceptive pill use and pregnancy rates. This paper will be supplemented by a planned review on this topic for the Cochrane collaboration, which will include statistical meta-analyses that estimate the combined effect of advance provision of emergency contraception on a variety of outcomes among all randomized controlled trials.3

...

In August 2006, we used the following strategies to search MEDLINE, POPLINE, EMBASE, and LILACS databases for studies that presented data comparing the effects of different levels of access to emergency contraceptive pills. The strategies included terms signifying emergency contraception combined (except for the LILACS database) with terms signifying access and had no time restriction.

...

We also examined reference lists from articles identified through the research and spoke with other experts in the field to find additional published or unpublished studies.

...

Our searches identified a total of 717 articles. Two authors (E.G.R. and J.T.) independently reviewed all information about these articles provided by the databases. We selected studies of any design that yielded primary data comparing effects of interventions or programs with different levels of access to emergency contraceptive pills. We excluded 694 from this review.......23 articles met our selection criteria. Two or three authors (E.G.R., J.T., and C.P.) then independently abstracted relevant data from the selected studies. We contacted authors of five of the studies to clarify the information presented in their publications. We resolved any discrepancies through consensus. We assessed the quality of the design, implementation, and analysis of each study, and when possible we tabulated the data on pregnancies and emergency contraceptive pill use.15 We did not perform statistical meta-analysis, because study design of our included studies differed substantially.

...

The 23 included studies were conducted in 10 countries, and all were reported between 1998 and 2006. Ten randomized trials and four cohort studies prospectively allocated women to either an increased access intervention group or a control group and followed up the women individually to ascertain outcomes (Table 1). These 14 studies enrolled a total of 13,564 women. In each of these studies, the intervention included provision of one or more free emergency contraceptive pill packages at enrollment that women could keep at home and use later if needed. The interventions differed in their aggressiveness....Thus, the difference in access between the intervention and control groups was less in some studies than in others.

...

Most of the 14 individually allocated studies had low power to detect even moderate differences in pregnancy rates between groups. Only four were designed with pregnancy as a planned primary outcome. In some of the studies, the study population was not at high risk for unintended pregnancy or abortion, as demonstrated by low rates in the control groups or nonintervention settings.20,21 Outcome ascertainment approaches also varied. Pregnancies were detected by participant report, supplemented in some studies by chart review and scheduled or indicated pregnancy testing. In four studies, pregnancies were not reported for the intervention and control groups. Data on emergency contraceptive pill use were obtained exclusively by participant report and was thus not verifiable. Planned follow-up duration ranged from 3 to 12 months. The proportion of enrolled women who did not complete the planned follow-up was very high (more than 30%) in at least four of the studies (Table 2).

...

An additional nine studies included in our review did not assign individual participants to intervention or control groups (Table 3). Rather, these studies compared population-level statistics in settings where the intervention was implemented to corresponding statistics in other times or settings. Interventions included legislation allowing distribution of emergency contraceptive pills over the counter or behind the counter from a pharmacist, provision of an advance supply of emergency contraceptive pills, implementation of a telephone prescription service, and introduction of a dedicated product by a pharmaceutical company. In the reports of these studies, information on factors other than the intervention that might have influenced the findings was limited or nonexistent. Some reports provided no evidence about the penetration of the intervention in the study community, so the proportion and characteristics of the population actually exposed was therefore unclear. These studies also suffered from other weaknesses akin to those noted for the studies using individual allocation, including populations at low risk for pregnancy, relatively easy emergency contraceptive pill access in the control settings, and possibly incomplete reporting of outcomes.

...

The specific emergency contraceptive pill regimens used in the 23 studies included the Yuzpe regimen (two doses of 100 mcg ethinyl estradiol plus 0.5 mg levonorgestrel taken 12 hours apart), the levonorgestrel-only regimen (two doses 0.75 mg levonorgestrel taken either together or 12 hours apart), and the mifepristone regimen (10 mg mifepristone).

None of the included studies found clinically or statistically significant differences between intervention and control groups in pregnancy or abortion rates (Tables 2 and 3). Of those that provided data on emergency contraceptive pill use, all but one9 showed that a substantially higher proportion of women in the intervention group than in the control group used emergency contraceptive pills. Several studies suggested that the intervention also increased promptness of use of emergency contraceptive pills,7,10,16,22,23,25 although one large trial did not confirm this effect.20

...

A substantial body of research is now available on the effects of improved access to emergency contraceptive pills. These data demonstrate convincingly that greater access increases use. However, to date, no study has shown that increased access to this method reduces unintended pregnancy or abortion rates on a population level. The specific interventions varied among the studies, and the quality of some of the studies was poor. Nevertheless, the consistency of their primary findings is hard to ignore.

Further research is clearly needed to inform funding agencies, family planning program managers, policy makers, and women in making decisions about spending limited resources on emergency contraceptive pills. One obvious question is prompted by the observation in many studies that poor access to the pills is not the only impediment to their use: even when women have emergency contraceptive pills available, they often fail to take them after the most risky coital acts. For example, four trials reported the proportion of pregnant women who took emergency contraceptive pills in the menstrual cycles in which pregnancy occurred—ie, who may have tried to prevent the pregnancy by taking the pills.16,20,21,24 In each trial, this proportion was less than 30% in both intervention and control groups. Qualitative studies have found that commonly reported reasons for nonuse of emergency contraceptive pills include failure to recognize the risk of pregnancy, neglect of perceived risk, stigma, and misperceptions about the method. Certainly, emergency contraceptive pills cannot reduce the risk of pregnancy unless they are actually used. Therefore, development and evaluation of strategies to overcome these barriers and maximize emergency contraceptive pill use seem imperative.

In addition, more precise estimates of the efficacy of emergency contraceptive pills are desirable. A recent analysis has confirmed that the levonorgestrel regimen, which is the form of emergency contraceptive pills most commonly used worldwide, is significantly more efficacious after a single coital act than no treatment. Specifically, this analysis suggested that we can be 95% confident that it reduces pregnancy risk by more than 23%.36 But just how much more remains poorly defined; the published efficacy figures calculated from currently available data on this regimen—on average, approximately 80%37,38—may overstate actual efficacy, possibly quite substantially.36,39 Clearly, if the method is only weakly efficacious, it is unlikely to produce a major reduction in unintended pregnancy rates no matter how often women use it. The best way to obtain reliable efficacy data would be by conducting a placebo-controlled randomized trial. Such a trial would need to be large to provide precise results, and would therefore be expensive. Furthermore, because it is already clear that emergency contraceptive pills are more effective than placebo, ethical issues and recruitment methods would need careful consideration.

Some have speculated that easier access to emergency contraceptive pills might promote risk taking, thereby offsetting the reduction in pregnancy risk when emergency contraceptive pills are actually used. However, the comparative trials have found almost no evidence of differences between intervention or control groups on either unprotected sex or compliance with primary contraceptive use.13,14,16,18–22,24 In addition, the three studies that collected data on sexually transmitted infections, an indicator of sex unprotected by condoms, also found no effect of the intervention.10,16,19 Additional research on this topic therefore does not seem a high priority.


The study's bottom line:

Because emergency contraception can safely reduce the risk of unintended pregnancy for individual women who use it, improved awareness of and access to the medication is certainly appropriate and desirable. Thus, the recent United States Food and Drug Administration decision to allow adults to purchase emergency contraceptive pills behind the counter is a welcome step for our country. However, previous expectations that improved access could produce a direct, substantial impact on a population level may have been overly optimistic. Ultimately, emergency contraception may contribute its greatest public health benefit indirectly, by providing an opportunity to encourage women who may be in a particularly receptive frame of mind to adopt a more effective contraceptive method or to use their current method more correctly and consistently. Numerous studies have found that women who use emergency contraceptive pills are subsequently likely to adopt more effective contraception,14,21,22,24,25 but rigorous research on this possibility remains to be conducted.

Labels: ,

Friday, March 09, 2007

Belief-Based Plan B Side Effects

No comment:

Sadie Fields is director of the Georgia Christian Alliance, formerly the state's branch of the Christian Coalition before splitting with the national group. She said she fears using drugs like Plan B unsupervised could be dangerous.

"Obviously, we don't like anything that interferes in the beginning of life," Fields said. "But I think that women's health concerns should be on that list also.

"There's no drug that does something so dramatic that is not going to have some dangerous potential side effects."


Okay, not a comment, but a question. I realize the role of a reporter is not [necessarily] that of an educator. So I can understand why the reporter, upon hearing Ms. Fields'--hmm, how should I put this politely--uninformed musings, didn't try to educate her on the basics. But then, if you're not going to use ignorance as a teaching opportunity, what's the reason for printing this type of quote? It's pure nonsense. It's the equivalent of asking a little kid their opinion on Plan B, and then reporting her statement on dinosaurs and the magic pill. How exactly is that relevant or newsworthy?

UPDATE:

The article linked in the post details the story of a Georgia woman who was refused Plan B at her local Kroger store. Today I noticed this follow-up:

ATLANTA - Kroger Co. said Friday it was reiterating its drug policies to all of its pharmacists after a Georgia woman claimed she was denied the so-called "morning after" pill at one of the company's stores.

The Cincinnati-based grocery chain said if its pharmacists object to fulfilling a request, the store must "make accommodations to have that prescription filled for our customer."

"We believe that medication is a private patient matter," said Meghan Glynn, a Kroger spokeswoman. "Our role as a pharmacy operator is to furnish medication in accordance with the doctor's prescription or as requested by a patient."


Good.

Labels: